A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).

Phase 3

Active, not recruiting

• Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastric Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
• Interventions: Drug: zolbetuximab; Drug: oxaliplatin; Drug: capecitabine; Drug: placebo

• Registration Number: NCT03653507
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called GEJ cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor.

There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat stomach cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the people taking part in those countries will leave this study and receive licensed zolbetuximab.

The main aim(s) of the study is(are) to determine the efficacy of zolbetuximab combined with chemotherapy compared to a placebo combined with chemotherapy in treating adults with Claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample of their cancer will also have the Claudin 18.2 protein. They may have been previously treated with certain standard therapies but have not been treated with chemotherapy for their cancer. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.

The study treatments are either zolbetuximab with chemotherapy or placebo with chemotherapy. People who take part will receive just one of the treatments by chance. Study treatment will be double-blinded. That means that the people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in cycles. The study treatment is given to people slowly through a tube into a vein. This is called an infusion. The chemotherapy is called CAPOX (capecitabine and oxaliplatin) and will be given as an infusion and also as tablets. People will have 1 infusion of either zolbetuximab or placebo together with oxaliplatin chemotherapy in 3-week (21-day) cycles. People will also take 1 tablet of capecitabine (chemotherapy) twice a day for the first 2 weeks (14 days) of each cycle. People may receive zolbetuximab or placebo until their cancer worsens, they cannot tolerate the treatment, or they need to start another cancer treatment. People will receive CAPOX for up to about 6 months (8 treatment cycles). After the 6 months, people may receive capecitabine chemotherapy only, until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will visit the clinic on certain days during their treatment. The study doctors will check if people had any medical problems from zolbetuximab or the other study treatments. Also, people in the study will have health checks. On some visits, they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample after their study treatment has finished. People will visit the clinic within 7 days after they stop their study treatment. People will be asked about any medical problems and will have a health check. People who start treatment with licensed zolbetuximab will not need to attend the clinic for further visits and will receive standard of care health checks. People who continue study treatment will visit the clinic at 1 and 3 months after they stop their study treatment. They will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

Detailed Description

After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study.

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-11-28
• Primary Completion: 2022-10-25
• Disposition First Submitted: 2023-10-23
• Results First Submitted: 2024-11-13
• Results First Submitted QC: 2025-01-24
• Results First Posted: 2025-01-27
• Disposition First Posted: 2025-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-16
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 507

Inclusion Criteria

• A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:

  • Not a woman of childbearing potential (WOCBP) OR
  • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.

• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study treatment administration.

• Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.

• A male subject with female partner(s) of childbearing potential:

  • must agree to use contraception during the treatment period and for 6 months after the final study treatment administration.

• A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.

• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration.

• Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.

• Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.

• Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.

• Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.

• Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)

• Subject has ECOG performance status 0 or 1.

• Subject has predicted life expectancy ≥ 12 weeks.

• Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

  • Hemoglobin (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
  • Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L
  • Platelets ≥ 100x10^9/L
  • Albumin ≥ 2.5 g/dL
  • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
  • Estimated creatinine clearance ≥ 30 mL/min
  • Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria

• Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to randomization.

• Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.

• Subject has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to randomization.

• Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.

• Subject has received other investigational agents or devices within 28 days prior to randomization.

• Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.

• Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.

• Subject has prior severe allergic reaction or intolerance to any component of CAPOX.

• Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency.

• Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.

• Subject has significant gastric bleeding and/or untreated gastric ulcers that exclude the subject from participation.

• Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

  • For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
  • Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
  • Subjects treated for HCV with undetectable viral load results are eligible.

• Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.

• Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.

• Subject has significant cardiovascular disease, including any of the following:

  • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
  • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes
  • QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
  • History or family history of congenital long QT syndrome
  • Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).

• Subject has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis from gastric/GEJ cancer..

• Subject has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.

• Subject has had a major surgical procedure ≤ 28 days prior to randomization.

  • Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.

• Subject has psychiatric illness or social situations that would preclude study compliance.

• Subject has another malignancy for which treatment is required.

• Subject has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolbetuximab plus CAPOX	zolbetuximab	Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
Zolbetuximab plus CAPOX	oxaliplatin	Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
Zolbetuximab plus CAPOX	capecitabine	Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
Placebo plus CAPOX	oxaliplatin	Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
Placebo plus CAPOX	placebo	Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.
Placebo plus CAPOX	capecitabine	Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	From the date of randomization until 47 months	PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 by independent review committee \[IRC\]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From the date of randomization untill 47 months	OS was defined as the time from the date of randomization until the date of death from any cause. Kaplan-Meier estimates was used.
Time to Confirmed Deterioration (TTCD) Using Physical Functioning as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)	From the date of randomization untill 47 months	TTCD: time from randomization to first clinically meaning full deterioration (CMFD) that was confirmed at the next scheduled visit.The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's change from baseline (CFB) exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used.
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25 Plus STO22 Belching Subscale	From the date of randomization untill 47 months	TTCD:time from randomization to first CMFD confirmed at next scheduled visit.OG25 evaluated gastric \& gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain, discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss.STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100;higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25. CMFD: if participant's CFB exceeded pre-specified threshold (per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier (KM) estimates was used.
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)	Predose on C2D1,C5D1,C9D1,C13D1,C17D1	Ctrough was defined as the predose concentration at the end of dosing interval.
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30	From the date of randomization untill 47 months	TTCD: time from randomization to first CMFD that was confirmed at the next scheduled visit.The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's CFB exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used.
Objective Response Rate (ORR)	From the date of randomization untill 47 months	ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.
Duration Of Response (DOR)	From first response (CR/PR) untill 47 months	DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From first dose untill 47 months	An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status	Baseline, cycle (C) 2 day (D) 1 through C40D1	ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire	Baseline, on day (D)1 from cycle (C) 2 through C29, 30-day follow up, 90-day follow up	The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.It is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state.
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire	Baseline, C2D1 through C29D1, 30-day follow up, 90-day follow up	OG25 evaluated gastric \& gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain \& discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss.STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100;higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25.
Change From Baseline in HRQoL Measured by Global Pain (GP)	Baseline, C2D1 through C29D1, 30-day follow up, 90-day follow up	The GP instrument is a single assessment of overall pain and participants were assessed in global pain according to the following response categories: 1= no pain (anymore), 2 = less pain, 3 = no change and 4 = more pain. Low pain scores are considered a better outcome than a high pain score.
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire	Baseline, C2D1 through C29D1, 30-day follow up, 90-day follow up	EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Number of Anti-drug Antibody (ADA) Positive Participants	Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow up	Immunogenicity will be measured by the number of participants that are ADA positive.

Trial Locations

Locations (165)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States

University of Kansas Cancer Center and Medical Pavilion; 🇺🇸 Fairway, Kansas, United States

Site PT35109; 🇵🇹 Braga, Portugal

Site TW88603; 🇨🇳 Taichung, Taiwan

Site AR54009; 🇦🇷 Buenos Aires, Argentina

Site AR54004; 🇦🇷 San Miguel de Tucumán, Argentina

Site AR54003; 🇦🇷 Viedma, Argentina

Site GR30007; 🇬🇷 Rio Patras, Greece

Site IE35301; 🇮🇪 Dublin, Ireland

Site JP81009; 🇯🇵 Matsuyama, Japan

Site JP81011; 🇯🇵 Tsukiji, Japan

Site KR82008; 🇰🇷 Jeollanam-do, Korea, Republic of

Site AR54006; 🇦🇷 Pergamino, Argentina

Site AR54001; 🇦🇷 San Miguel De Tucuman, Argentina

Site HR38503; 🇭🇷 Zagreb, Croatia

Site GR30001; 🇬🇷 Athens, Greece

Site GR30004; 🇬🇷 Heraklion, Greece

Site GR30002; 🇬🇷 Thessaloniki, Greece

Site GR3006; 🇬🇷 Thessaloniki, Greece

Site JP81008; 🇯🇵 Akashi, Hyogo, Japan

Site KR82002; 🇰🇷 Daegu, Korea, Republic of

Site KR82014; 🇰🇷 Incheon, Korea, Republic of

Site KR82010; 🇰🇷 Jeonju-si, Korea, Republic of

Site KR82011; 🇰🇷 Seongnam-si, Korea, Republic of

Site MY60005; 🇲🇾 Kuala Lumpur, Malaysia

Site PT35111; 🇵🇹 Guimaraes, Portugal

Site KR82012; 🇰🇷 Seoul, Korea, Republic of

Site KR82015; 🇰🇷 Seoul, Korea, Republic of

Site MY60002; 🇲🇾 Kuala Lumpur, Malaysia

Site NL31004; 🇳🇱 Groningen, Netherlands

Site CA15003; 🇨🇦 Chicoutimi, Quebec, Canada

Site CA15004; 🇨🇦 Calgary, Canada

Site HR38501; 🇭🇷 Varazdin, Croatia

Site HR38502; 🇭🇷 Zagreb, Croatia

Site GR30003; 🇬🇷 Larissa, Greece

Site JP81005; 🇯🇵 Utsunomiya, Tochigi, Japan

Site KR82006; 🇰🇷 Goyang-si, Korea, Republic of

Site KR82007; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site JP81003; 🇯🇵 Kawasaki, Kanagawa, Japan

Site KR82009; 🇰🇷 Suwon, Korea, Republic of

Site RO40005; 🇷🇴 Cluj-Napoca, Romania

Site RO40007; 🇷🇴 Cluj-Napoca, Romania

Site RO40001; 🇷🇴 Iasi, Romania

Site RO40006; 🇷🇴 Iasi, Romania

Site RO40008; 🇷🇴 Timisoara, Romania

Site TH66009; 🇹🇭 Bangkok, Thailand

Site TH66001; 🇹🇭 Muang, Thailand

Site TH66008; 🇹🇭 Watthana, Thailand

Site KR82013; 🇰🇷 Seoul, Korea, Republic of

Site JP81004; 🇯🇵 Kita-gun, Japan

Site JP81012; 🇯🇵 Koto-ku, Japan

Site MY60003; 🇲🇾 Kuala Lumpur, Malaysia

Site PT35102; 🇵🇹 Lisboa, Portugal

Site PT35101; 🇵🇹 Setubal, Portugal

Site KR82001; 🇰🇷 Seoul, Korea, Republic of

Site TH66011; 🇹🇭 Laksi, Thailand

Site TH66006; 🇹🇭 Pathumthani, Thailand

Site TH66004; 🇹🇭 Songkla, Thailand

Site TR90011; 🇹🇷 Malatya, Turkey

Site CA15002; 🇨🇦 Rimouski, Quebec, Canada

Site TH66002; 🇹🇭 Bangkok, Thailand

Site TH66005; 🇹🇭 Bangkok, Thailand

Site PT35106; 🇵🇹 Lisboa, Portugal

Site PT35108; 🇵🇹 Porto, Portugal

Site TR90012; 🇹🇷 Bornova, Turkey

Site TR90010; 🇹🇷 Istanbul, Turkey

Site TR90013; 🇹🇷 Konyaalti, Turkey

Site KR82003; 🇰🇷 Seoul, Korea, Republic of

Site TW88604; 🇨🇳 Taipei, Taiwan

Site MY60001; 🇲🇾 Georgetown, Malaysia

Site MY60004; 🇲🇾 Kota Kinabalu, Malaysia

Site NL31003; 🇳🇱 Tilburg, Netherlands

Site PT35110; 🇵🇹 Coimbra, Portugal

Site PT35104; 🇵🇹 Santa Maria da Feira, Portugal

Site TW88602; 🇨🇳 Kaohsiung, Taiwan

Site TH66003; 🇹🇭 Muang, Thailand

Site PT35107; 🇵🇹 Vila Real, Portugal

Site TR90003; 🇹🇷 Atakum, Turkey

Site TR90015; 🇹🇷 Istanbul, Turkey

Site TR90004; 🇹🇷 Balcali, Turkey

Site TR90007; 🇹🇷 Konya, Turkey

Site TR90001; 🇹🇷 Bursa, Turkey

Site TR90002; 🇹🇷 Istanbul, Turkey

Site CN86049; 🇨🇳 Changchun, China

Site CN86017; 🇨🇳 Shijiazhuang, China

Site CN86040; 🇨🇳 Tianjin, China

Site JP81006; 🇯🇵 Kashiwa, Japan

Site JP81002; 🇯🇵 Chiba, Japan

Site ES34004; 🇪🇸 Pamplona, Spain

Site TH66007; 🇹🇭 Bangkok, Thailand

Site TH66010; 🇹🇭 Pathumwan, Thailand

Site TR90008; 🇹🇷 Pendik, Istanbul, Turkey

Site GB44002; 🇬🇧 Bristol, United Kingdom

Site GB44004; 🇬🇧 Cardiff, United Kingdom

Site GB44001; 🇬🇧 London, United Kingdom

Prisma Health Cancer Institute; 🇺🇸 Boiling Springs, South Carolina, United States

Pacific Cancer Care; 🇺🇸 Monterey, California, United States

Weill Cornell Medical College (WCMC); 🇺🇸 New York, New York, United States

New Mexico Oncology Hematology; 🇺🇸 Albuquerque, New Mexico, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology; 🇺🇸 Houston, Texas, United States

Site GB44005; 🇦🇷 Northwood, Argentina

Site CN86034; 🇨🇳 Fuzhou, Fujian, China

Site CN86032; 🇨🇳 Haikou, Hainan, China

Site CN86037; 🇨🇳 Fuzhou, Fujian, China

Site CN86012; 🇨🇳 Zhengzhou, Henan, China

Site CN86029; 🇨🇳 Changsha, Hunan, China

Site CN86043; 🇨🇳 Hengyang, Hunan, China

Site CN86027; 🇨🇳 Suzhou, Jiangsu, China

Site CN86046; 🇨🇳 Wuxi, Jiangsu, China

Site CN86007; 🇨🇳 Hangzhou, Zhejiang, China

Site CN86044; 🇨🇳 Baoding, China

Site CN86035; 🇨🇳 Beijing, China

Site CN86050; 🇨🇳 Beijing, China

Site CN86021; 🇨🇳 Changzhou, China

Site CN86025; 🇨🇳 Bengbu, China

Site CN86002; 🇨🇳 Changchun, China

Site CN86042; 🇨🇳 Guangzhou, China

Site CN86053; 🇨🇳 Changchun, China

Site CN86039; 🇨🇳 Chengdu, China

Site CN86052; 🇨🇳 Dalian, China

Site CN86054; 🇨🇳 Dalian, China

Site CN86051; 🇨🇳 Haebrin, China

Site CN86001; 🇨🇳 Guangzhou, China

Site CN86015; 🇨🇳 Fuzhou, China

Site CN86038; 🇨🇳 Linyi, China

Site CN86036; 🇨🇳 Hangzhou, China

Site CN86016; 🇨🇳 Nanjing, China

Site CN86045; 🇨🇳 Nanning, China

Site CN86014; 🇨🇳 Shanghai, China

Site CN86026; 🇨🇳 Shantou, China

Site CN86047; 🇨🇳 Shenyang, China

Site CN86009; 🇨🇳 Tianjin, China

Site CN86031; 🇨🇳 Urumchi, China

Site CN86004; 🇨🇳 Wuhan, China

Site CN86005; 🇨🇳 Wuhan, China

Site CN86013; 🇨🇳 Xi'an, China

Site CN86030; 🇨🇳 Xiamen, China

Site CN86011; 🇨🇳 Xuzhou, China

Site CN86024; 🇨🇳 Zhengzhou, China

Site GR30005; 🇬🇷 Neo Faliro, Piraeus, Greece

Site IE35302; 🇮🇪 Dublin, Ireland

Site JP81001; 🇯🇵 Yokohama, Kanagawa, Japan

Site JP81007; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Site JP81010; 🇯🇵 Suita, Osaka, Japan

Site PT35105; 🇵🇹 Porto, Portugal

Site RO40002; 🇷🇴 Bucharest, Romania

Site RO40003; 🇷🇴 Craiova, Romania

Site RO40004; 🇷🇴 Floresti, Romania

Site ES34009; 🇪🇸 Barcelona, Spain

Site ES34005; 🇪🇸 Coruña, Spain

Site ES34001; 🇪🇸 Elche, Spain

Site ES34008; 🇪🇸 Madrid, Spain

Site ES34002; 🇪🇸 Madrid, Spain

Site ES34003; 🇪🇸 Madrid, Spain

Site ES34013; 🇪🇸 Madrid, Spain

Site ES34007; 🇪🇸 Valencia, Spain

Site ES34012; 🇪🇸 Valencia, Spain

Site ES34011; 🇪🇸 Malaga, Spain

Site TW88605; 🇨🇳 Tianan, Taiwan

Site ES34006; 🇪🇸 Barcelona, Spain

Site ES34010; 🇪🇸 Barcelona, Spain

Ochsner Clinic CCOP; 🇺🇸 New Orleans, Louisiana, United States

Utah Cancer Specialist; 🇺🇸 Salt Lake City, Utah, United States

Montefiore Medical Center (MMC); 🇺🇸 Bronx, New York, United States