A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

Phase 2

Active, not recruiting

• Conditions: Pancreatic Cancer; Metastatic Pancreatic Cancer; Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: zolbetuximab; Drug: nab-paclitaxel; Drug: gemcitabine

• Registration Number: NCT03816163
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for peop...

Detailed Description

This study will have a safety lead in phase and a randomization phase.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-25
• Study Start: 2019-03-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 393

Inclusion Criteria

• A female subject is eligible to participate if she is not pregnant or lactating 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 at least 6 months after the final study drug administration.

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

• Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.

• A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.

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

• Subject agrees not to participate in other interventional studies while receiving study drug in present study.

• Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.

• Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy.

  • Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed
  • If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy.
  • Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible.

• Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.

• Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing

• Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Subject has predicted life expectancy ≥ 12 weeks.

• Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used.

  • Hemoglobin ≥ 9 g/dl (no transfusion within 14 days of start of study treatment)
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (≤ 5 x ULN if liver metastases are present)
  • Estimated creatinine clearance ≥ 30 mL/min
  • Prothrombin time/international normalized ratio (INR) and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

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Exclusion Criteria

• Subject has received other investigational treatment within 28 days prior to randomization.

• Subject has received radiotherapy for metastatic pancreatic adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.

• Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject 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 prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies.

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

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

  1. For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded.
  2. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible.
  3. Subjects treated for hepatitis C with undetectable viral load results are eligible.

• Subject has a history of interstitial pneumonia or pulmonary fibrosis.

• Subject has pleural effusion or ascites ≥ Grade 3.

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

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

• Subject has significant cardiovascular disease, including:

  • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident 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;
  • Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.)

• Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma.

• Subject has known peripheral sensory neuropathy ≥ Grade 2 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 without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zolbetuximab +nab-paclitaxel + gemcitabine	zolbetuximab	Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
zolbetuximab +nab-paclitaxel + gemcitabine	nab-paclitaxel	Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
nab-paclitaxel + gemcitabine	nab-paclitaxel	Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
nab-paclitaxel + gemcitabine	gemcitabine	Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
zolbetuximab +nab-paclitaxel + gemcitabine	gemcitabine	Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 65 months	OS is defined as the time from the date of randomization until the date of death from any cause.
Safety assessed by incidence of treatment emergent adverse events (TEAE)	Up to 65 months	Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Number of participants with vital sign abnormalities and /or adverse events (AEs)	Up to 65 months	Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events	Up to 65 months	12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
Dose Limiting Toxicities (DLT) - (safety lead in)	Up to 28 days	Incidence of dose limiting toxicities.
Safety assessed by incidence of serious adverse events (SAE)	Up to 65 months	Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Number of participants with laboratory value abnormalities and/or adverse events (AEs)	Up to 65 months	Number of participants with potentially clinically significant laboratory values.
Safety assessed by Adverse Events (AEs)	Up to 65 months	An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 me...
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events	Up to 65 months	Number of participants with potentially clinically significant ECOG performance status values. 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;...

Secondary Outcome Measures

Name	Time	Method
Number of anti-drug antibody (ADA) Positive Participants	Up to 65 months	Immunogenicity will be measured by the number of participants that are ADA positive.
Change in CA (Cancer Antigen) 19-9	Baseline up to 65 months	Change from baseline in serum CA19-9 will be assessed.
PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)	Up to 65 months	Ctrough will be derived from the PK serum samples collected.
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)	Up to 30 days	AUCinf will be derived from the PK plasma samples collected.
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)	Up to 30 days	AUClast will be derived from the PK plasma samples collected.
PK of Nab-P: Maximum Concentration (Cmax)	Up to 30 days	Cmax will be derived from the PK plasma samples collected.
PK of Nab-P: Time of Maximum Concentration (Tmax)	Up to 30 days	Tmax will be derived from the PK plasma samples collected.
Progression Free Survival (PFS)	Up to 65 months	PFS is 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 investigator evaluation or death from any cause, whichever is earliest.
Disease Control Rate (DCR)	Up to 65 months	DCR is defined as the proportion of participants who have best overall response of stable disease, complete response (CR) or partial response (PR) as assessed by investigator evaluation per RECIST 1.1
Objective Response Rate (ORR)	Up to 65 months	ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
PK of Nab-P: Terminal Elimination Half-life (T1/2)	Up to 30 days	T1/2 will be derived from the PK plasma samples collected.
PK of Nab-P: Clearance (CL)	Up to 30 days	CL will be derived from the PK plasma samples collected.
PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)	Up to 30 days	Vz will be derived from the PK plasma samples collected.
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)	Up to 30 days	AUCinf will be derived from the PK plasma samples collected.
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)	Up to 30 days	AUClast will be derived from the PK plasma samples collected.
PK of gemcitabine: Maximum Concentration (Cmax)	Up to 30 days	Cmax will be derived from the PK plasma samples collected.
PK of gemcitabine: Time of Maximum Concentration (Tmax)	Up to 30 days	Tmax will be derived from the PK plasma samples collected.
PK of gemcitabine: Terminal Elimination Half-life (T1/2)	Up to 30 days	T1/2 will be derived from the PK plasma samples collected.
PK of gemcitabine: Clearance (CL)	Up to 30 days	CL will be derived from the PK plasma samples collected.
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)	Up to 30 days	Vz will be derived from the PK plasma samples collected.
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)	Up to 65 months	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. Participants rate items on a four...
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)	Up to 65 months	EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)	Up to 65 months	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome 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.; ...
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale	Up to 65 months	The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale	Up to 65 months	The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Time to Improvement of pancreatic pain as measured by Quality-of-Life Questionnaire - Core Questionnaire (QLQ-C30)	Up to 65 months	The 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. Participants rate items on a four-point...
Time to worsening of global health status (GHS)/quality of life (QoL) as measured by QLQ-C30	Up to 65 months	The 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. Participants rate items on a four-point...
Time to Improvement of pancreatic pain as measured by Quality of Life Questionnaire - Pancreatic Cancer Module 26 (QLQ-PAN26)	Up to 65 months	EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Time to worsening of GHS/QoL as measured by QLQ-PAN26	Up to 65 months	EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Time to Improvement of pancreatic pain as measured by PGIS	Up to 65 months	The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Time to worsening of GHS/QoL as measured by PGIS	Up to 65 months	The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Duration Of Response (DOR)	Up to 65 months	DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earliest.

Trial Locations

Locations (136)

Lynn Cancer Institute; 🇺🇸 Boca Raton, Florida, United States

Site TR90002; 🇹🇷 Istanbul, Turkey

St. Joseph Heritage Medical Group; 🇺🇸 Fullerton, California, United States

Cancer Treatment Centers of Atlanta; 🇺🇸 Newnan, Georgia, United States

Midstate Medical Center; 🇺🇸 Meriden, Connecticut, United States

Site BR55011; 🇧🇷 Sao Paulo, Brazil

Site BR55009; 🇧🇷 Centro Passo Fundo, Brazil

Site CN86020; 🇨🇳 Guangdong, China

Site CN86005; 🇨🇳 Jiangsu, China

Site BR55010; 🇧🇷 Sao Paulo, Brazil

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Novant Health Presbyterian Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Site AU61005; 🇦🇺 Fitzroy, Victoria, Australia

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Vista Oncology; 🇺🇸 Olympia, Washington, United States

Site ES34026; 🇪🇸 Malaga, Spain

Site BR55008; 🇧🇷 Rio Grande Do Sul, Brazil

Site BR55004; 🇧🇷 Santa Catarina, Brazil

Site FR33006; 🇫🇷 Chambray, Cedex 9, France

Site FR33003; 🇫🇷 Aquitaine, Pessac, France

Site FR33017; 🇫🇷 Rouen, Normandy, France

Site FR33007; 🇫🇷 Strasbourg, France

Site JP81011; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Site CN86014; 🇨🇳 Beijing, China

Site ES34004; 🇪🇸 Llobregat, Barcelona, Spain

Site CN86026; 🇨🇳 Changchun, China

Site CN86002; 🇨🇳 Hubei, China

Site CN86011; 🇨🇳 Jiangsu, China

Site CN86025; 🇨🇳 Jiangsu, China

Site CN86018; 🇨🇳 Zhejiang, China

Site CN86010; 🇨🇳 Zhengzhou, China

Site FR33008; 🇫🇷 Besancon, Besancon Cedex, France

Site ES34022; 🇪🇸 Cordoba, Spain

Site ES34006; 🇪🇸 Madrid, Spain

Site FR33005; 🇫🇷 Pringy Cedex, France

Site KR82005; 🇰🇷 Seongnam-Si, Gyeonggi-do, Korea, Republic of

Site ES34003; 🇪🇸 Pamplona, Navarra, Spain

Site JP81014; 🇯🇵 Koto-ku, Tokyo, Japan

Site MX52003; 🇲🇽 San Luis Potosi, Mexico

Site TW88609; 🇨🇳 Taipei City, Taiwan

Site IT39006; 🇮🇹 Rozzano, Milan, Italy

Site FR33010; 🇫🇷 Brest, Brest Cedex, France

Site FR33013; 🇫🇷 Villejuif, Villejuif Cedex, France

Site JP81004; 🇯🇵 Fukuoka, Japan

Site IT39003; 🇮🇹 Milan, Italy

Site ES34009; 🇪🇸 Madrid, Spain

Site FR33012; 🇫🇷 Herblain, Herblain Cedex, France

Site FR33018; 🇫🇷 Bordeaux, France

Site KR82009; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site JP81007; 🇯🇵 Nagoya, Aichi, Japan

Site JP81001; 🇯🇵 Kashiwa, Chiba, Japan

Site JP81013; 🇯🇵 Mitaka, Tokyo, Japan

Site MX52005; 🇲🇽 Veracruz, Mexico

Site IT39002; 🇮🇹 Cremona, Italy

Site IT39010; 🇮🇹 Lombardia, Italy

Site KR82008; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Site FR33002; 🇫🇷 Grenoble, France

Site JP81003; 🇯🇵 Kashihara, Nara, Japan

Site FR33021; 🇫🇷 Nice Cedex 2, France

Site KR82010; 🇰🇷 Daegu, Korea, Republic of

Site ES34013; 🇪🇸 Barcelona, Spain

Site IT39004; 🇮🇹 Candiolo, Torino, Italy

Site TR90004; 🇹🇷 Ankara, Turkey

Site JP81012; 🇯🇵 Chuo-ku, Tokyo, Japan

Site TW88602; 🇨🇳 Taichung City, Taiwan

Site JP81002; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Site TR90003; 🇹🇷 Diyarbakir, Turkey

Site JP81010; 🇯🇵 Osaka, Japan

Site JP81006; 🇯🇵 Yokohama, Kanagawa, Japan

Site JP81009; 🇯🇵 Wakayama, Japan

Site TW88608; 🇨🇳 New Taipei City, Taiwan

Site TR90006; 🇹🇷 Ankara, Turkey

Site IR35301; 🇮🇪 Elm Park, Dublin, Ireland

Site BR55012; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Site CN86012; 🇨🇳 Harbin, China

Site CN86009; 🇨🇳 Chongqing, China

Site CN86004; 🇨🇳 Guangdong, China

Site CN86016; 🇨🇳 Guangzhou, China

Site CN86024; 🇨🇳 Shan XI, China

Site CN86023; 🇨🇳 Shandong, China

Site CN86006; 🇨🇳 Shanghai, China

Site CN86013; 🇨🇳 Shanghai, China

Site CN86001; 🇨🇳 Beijing, China

Site CN86007; 🇨🇳 Tianjin, China

Site CN86022; 🇨🇳 Xinjiang, China

Site CN86003; 🇨🇳 Zhejiang, China

Site IT39014; 🇮🇹 Toscana, Italy

Site FR33009; 🇫🇷 Nancy, Nancy Cedex, France

Site FR33001; 🇫🇷 Bayonne Cedex, France

Site FR33023; 🇫🇷 Pierre Benite, France

Site FR33019; 🇫🇷 Roche-Sur-Yon, France

Site KR82006; 🇰🇷 Seoul, Korea, Republic of

TOI Clinical research; 🇺🇸 Whittier, California, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Northwell Health Cancer Institute; 🇺🇸 Lake Success, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Site AU61007; 🇦🇺 Wollongong, New South Wales, Australia

Site AU61006; 🇦🇺 Warrnambool, Victoria, Australia

Site CN86008; 🇨🇳 Beijing, China

Site CN86019; 🇨🇳 Shanghai, China

Site FR33016; 🇫🇷 La Chaussee Saint Victor, Loir-et-Cher, France

Site FR33015; 🇫🇷 Caen, Cedex 5, France

Site FR33014; 🇫🇷 Plerin, France

Site IT39008; 🇮🇹 Veneto, Italy

Site JP81005; 🇯🇵 Sapporo, Hokkaido, Japan

Site JP81015; 🇯🇵 Ube, Yamaguchi, Japan

Site KR82003; 🇰🇷 Seoul, Korea, Republic of

Site KR82004; 🇰🇷 Seoul, Korea, Republic of

Site MX52004; 🇲🇽 Distrito Federal, Mexico

Site ES34014; 🇪🇸 Caceres, Spain

Site ES34018; 🇪🇸 Barcelona, Spain

Site TR90001; 🇹🇷 Konya, Turkey

Ochsner Health System; 🇺🇸 New Orleans, Louisiana, United States

Site KR82002; 🇰🇷 Seoul, Korea, Republic of

Site ES34010; 🇪🇸 Barcelona, Spain

Site KR82001; 🇰🇷 Seoul, Korea, Republic of

Site AU61008; 🇦🇺 Gosford, New South Wales, Australia

David C Pratt Cancer Center; 🇺🇸 Creve Coeur, Missouri, United States

MultiCare Regional Cancer Center - Gig Harbor; 🇺🇸 Gig Harbor, Washington, United States

Virginia Mason; 🇺🇸 Seattle, Washington, United States

Site KR82007; 🇰🇷 Seoul, Korea, Republic of

Site ES34005; 🇪🇸 Lleida, Spain

Site ES34015; 🇪🇸 Madrid, Spain

Site ES34007; 🇪🇸 Barcelona, Spain

Site ES34017; 🇪🇸 Santiago de Compostela, Spain

Site ES34021; 🇪🇸 Barcelona, Spain

Baptist Health; 🇺🇸 Miami, Florida, United States

Norton Cancer Institute (NCI); 🇺🇸 Louisville, Kentucky, United States

Novant Health; 🇺🇸 Winston-Salem, North Carolina, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

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

Site TW88601; 🇨🇳 Taipei City, Taiwan