A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

Registration Number
NCT05365581
Lead Sponsor
Astellas Pharma Global Development, Inc.
Brief Summary

Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein called on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor.
...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
305
Inclusion Criteria

  • Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).

  • Female participant is not pregnant, confirmed by serum pregnancy test and medical evaluation by interview and at least 1 of the following conditions apply:

    • Not a woman of childbearing potential (WOCBP)
    • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.

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

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

  • Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after the final study intervention administration.

  • Male participant must not donate sperm during the treatment period and for 6 months after the final study intervention administration.

  • Male participant with 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 intervention administration.

  • Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.

  • Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.

  • Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

  • Participant has QT interval by Fredericia (QTcF) =< 470 msec.

  • Participant agrees not to participate in another interventional study while receiving study Intervention in the present study.

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

  • Participant has predicted life expectancy >= 12 weeks.

  • Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained >= 2 weeks after any blood transfusion.

Monotherapy Disease specific Criteria: Gastric/GEJ Cancer

  • Participant has histologically confirmed gastric/gastroesophageal junction (GEJ) adenocarcinoma.

  • Escalation: Participant with gastric/GEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).

    • Unique to South Korea: Participant with gastric/GEJ adenocarcinoma who has refused standard approved therapies is not allowed.

  • Expansion: Participant with gastric/GEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.

Monotherapy Disease specific Criteria: Pancreatic Cancer

  • Participant has histologically or cytologically confirmed pancreatic adenocarcinoma.

  • Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).

    • Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.

  • Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.

For all participants in combination therapy administration:

  • If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.

Combination Therapy Disease specific Criteria: ASP2138 in Combination with Pembrolizumab and mFOLFOX6 as First-line Therapy in Gastric/GEJ Cancer

  • Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.
  • Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
  • Participant with gastric/GEJ adenocarcinoma has progressed and must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.
  • Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.

Combination Therapy Disease specific Criteria: ASP2138 in Combination with Ramucirumab and Paclitaxel as Second-line Therapy in Gastric/GEJ Cancer Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.

  • Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
  • Participant with gastric/GEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression during or within 4 months of the last dose of first line platinum and fluoropyrimidine doublet or disease progression during or after perioperative fluorouracil, leucovorin, oxaliplatin and docetaxel [FLOT]).

Combination Therapy Disease specific Criteria: ASP2138 in Combination with mFOLFIRINOX as First-line Therapy in Pancreatic Cancer

  • Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
  • Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.
  • Participant has pancreatic adenocarcinoma, has progressed and must not have received prior systemic anticancer therapy for their advanced disease.
Read More
Exclusion Criteria

  • Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.

  • Participant has any condition which makes the participant unsuitable for study participation.

  • Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.

  • Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.

  • Participant weighs < 40 kg.

  • Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant 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 daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.

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

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

  • Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.

  • Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts >= 350 cells/µL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for human immunodeficiency virus (HIV) infection should be conducted per local requirements.

  • Participant is known to have active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.

    • For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test will be performed and if positive the participant will be excluded.
    • Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.
    • Participant treated for HCV with undetectable viral load results are eligible

  • Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.

  • Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.

  • Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.

  • Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.

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

  • Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.

  • Participant has received radiotherapy metastatic or for locally advanced unresectable gastric/GEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention and has NOT recovered from any related toxicity.

  • Participant has another malignancy for which treatment is required.

  • Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose escalation cohorts. However, a participant who has received CLDN18.2-targeted therapy greater than 28 days or 5 half-lives (whichever is longer) prior to first dose study intervention administration is eligible for dose expansion cohorts only, with the exception of participants who have experienced Grade >= 3 gastrointestinal toxicity after receiving an CLDN18.2-targeted therapy.

  • Participant has a history or complication of interstitial lung disease.

China Specific:

Participant who has received treatment with herbal medications that have known antitumor activity within 28 days prior to first dose of study treatment.

For all participants in combination therapy administration:

  • Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab and mFOLFOX6 [all components], ramucirumab and paclitaxel or mFOLFIRINOX [all components]).
  • For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements).
  • Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants 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 daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of combination therapy administration) are allowed.
  • Participant is known to have HIV infection.
  • NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells/µL and no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.
  • NOTE: Screening for HIV infection should be conducted per local requirements.
  • Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.
  • Participant has a history of ascites requiring drainage more than twice in the past 7 days.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Monotherapy Dose Escalation (Phase 1)ASP2138A dose escalation design will be used to determine the Maximum Tolerated Dose (MTD) and/ or the Recommended Phase 2 Dose (RP2D) regimens to be further evaluated in the Monotherapy Dose Expansion arms. Monotherapy Dose escalation part consists of six parts (Part A, B, C, D, E, and F), and approximately 86 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in each part. The study will open with the Part A dosing schedule, while subsequent cohorts will be opened sequentially or in parallel based upon sponsor review of emerging data.
Monotherapy Dose Expansion (Phase 1b) Gastric/GEJ cancerASP2138Participants will receive ASP2138 at the candidate RP2D regimens determined in Monotherapy Dose Escalation arm.
Monotherapy Dose Expansion (Phase 1b) Pancreatic cancerASP2138Participants will receive ASP2138 at the candidate RP2D regimens determined in Monotherapy Dose Escalation arm.
Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ CancerASP2138A dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. In combination dose escalation part G approximately 24 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with pembrolizumab and mFOLFOX6 as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ CancerPembrolizumabA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. In combination dose escalation part G approximately 24 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with pembrolizumab and mFOLFOX6 as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ CancerASP2138A dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy.
Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ CancerRamucirumabA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy.
Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ CancerPaclitaxelA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy.
Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic CancerASP2138A dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with mFOLFIRINOX as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic CancerOxaliplatinA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with mFOLFIRINOX as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic CancerLeucovorinA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with mFOLFIRINOX as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic CancerFluorouracilA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with mFOLFIRINOX as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic CancerIrinotecanA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with mFOLFIRINOX as first line therapy.
ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerASP2138Participants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& mFOLFOX6 as first line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerPembrolizumabParticipants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& mFOLFOX6 as first line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerOxaliplatinParticipants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& mFOLFOX6 as first line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerLeucovorinParticipants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& mFOLFOX6 as first line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerFluorouracilParticipants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& mFOLFOX6 as first line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerASP2138Participants will receive candidate RP2D regimens of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic CancerASP2138Participants will receive candidate RP2D regimens of ASP2138 in combination with mFOLFIRINOX as first line therapy in pancreatic cancer determined in Combination Therapy Dose Escalation arm in combination with mFOLFIRINOX as first line therapy in pancreatic cancer.
Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ CancerLeucovorinA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. In combination dose escalation part G approximately 24 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with pembrolizumab and mFOLFOX6 as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ CancerFluorouracilA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. In combination dose escalation part G approximately 24 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with pembrolizumab and mFOLFOX6 as first line therapy.
Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ CancerOxaliplatinA dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. In combination dose escalation part G approximately 24 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with pembrolizumab and mFOLFOX6 as first line therapy.
ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerPaclitaxelParticipants will receive candidate RP2D regimens of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerRamucirumabParticipants will receive candidate RP2D regimens of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy determined in Combination Therapy Dose Escalation arm.
ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic CancerOxaliplatinParticipants will receive candidate RP2D regimens of ASP2138 in combination with mFOLFIRINOX as first line therapy in pancreatic cancer determined in Combination Therapy Dose Escalation arm in combination with mFOLFIRINOX as first line therapy in pancreatic cancer.
ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic CancerIrinotecanParticipants will receive candidate RP2D regimens of ASP2138 in combination with mFOLFIRINOX as first line therapy in pancreatic cancer determined in Combination Therapy Dose Escalation arm in combination with mFOLFIRINOX as first line therapy in pancreatic cancer.
ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic CancerLeucovorinParticipants will receive candidate RP2D regimens of ASP2138 in combination with mFOLFIRINOX as first line therapy in pancreatic cancer determined in Combination Therapy Dose Escalation arm in combination with mFOLFIRINOX as first line therapy in pancreatic cancer.
ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic CancerFluorouracilParticipants will receive candidate RP2D regimens of ASP2138 in combination with mFOLFIRINOX as first line therapy in pancreatic cancer determined in Combination Therapy Dose Escalation arm in combination with mFOLFIRINOX as first line therapy in pancreatic cancer.
Primary Outcome Measures
NameTimeMethod
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Dose Escalation)Up to 28 days

A DLT is defined as any of the prespecified Adverse Events (AEs) (graded using National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0, except cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\] which are graded using American Society for Transplantation and Cellula...

Number of participants with Adverse Events (AEs)Up to 15 months

An AE is any untoward medical occurrence temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 study intervention...

Number of participants with serious AEs (SAEs)Up to 15 months

An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important events.

Number of participants with laboratory value abnormalitiesUp to 13 months

Number of participants with potentially clinically significant laboratory values.

Number of participants with vital sign abnormalitiesUp to 15 months

Number of participants with potentially clinically significant vital sign values.

Number of participants with electrocardiogram (ECG) abnormalitiesUp to 12 months

Number of participants with potentially clinically significant ECG values.

Number of participants with physical exam abnormalitiesUp to 13 months

Number of participants with potentially clinically significant physical exam values.

Number of participants at each grade of the Eastern Cooperative Oncology Group (ECOG) performance statusUp to 13 months

The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

Secondary Outcome Measures
NameTimeMethod
Pharmacokinetics (PK) of ASP2138 in serum: Area under the concentration-time curve (AUC) from the time of dosing to the start of the next dosing interval at multiple dose conditions (AUCtau)Up to 12 months

AUCtau will be recorded from the PK serum samples collected.

PK of ASP2138 in serum: maximum concentration (Cmax)Up to 12 months

Cmax will be recorded from the PK serum samples collected.

PK of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)Up to 12 motnhs

Ctrough will be recorded from the PK serum samples collected.

PK of ASP2138 in serum: time of the maximum concentration (Tmax)Up to 12 months

Tmax will be recorded from the PK serum samples collected.

Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 1b dose expansion)Up to 21 months

ORR is defined as the proportion of participants for each dosing scheme whose best overall response is rated as confirmed complete response (CR) or partial response (PR) per RECIST 1.1.

Disease control rate (DCR) per RECIST 1.1 (Phase 1b dose expansion)Up to 21 months

DCR is defined as the proportion of participants for each dosing scheme whose best overall response is rated as confirmed CR, PR or stable disease (SD) per RECIST 1.1.

Change from baseline in serum carbohydrate antigen 19-9 (CA19-9) (pancreatic only) (Phase 1b dose expansion)up to 21 months

Serum CA19-9 level will be assessed by local laboratory in participants with pancreatic cancer.

Change from baseline in claudin (CLDN) 18.2 tumor expression levelUp to 6 weeks

Comparison of CLDN18.2 expression in baseline versus on-treatment tumor biopsies will be performed.

Change from baseline in programmed death-ligand 1 (PD-L1) tumor expression levelUp to 6 weeks

Comparison of PD-L1 expression in baseline versus on-treatment tumor biopsies will be performed.

Trial Locations

Locations (38)

Site KR82003

🇰🇷

Seocho-gu, Seoul, Korea, Republic of

Site KR82005

🇰🇷

Seodaemun-gu, Seoul, Korea, Republic of

Site KR82001

🇰🇷

Guro-gu, Seoul, Korea, Republic of

Site KR82002

🇰🇷

Jongno-gu, Seoul, Korea, Republic of

The First Affiliated Hospital, College of Medicine, Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

University of California Irvine Medical Center

🇺🇸

Orange, California, United States

UCLA Dept of Medicine - Hematology/Oncology, Santa Monica

🇺🇸

Santa Monica, California, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

University of Kansas Cancer Center

🇺🇸

Westwood, Kansas, United States

Rutgers Cancer Institute of New Jersey

🇺🇸

New Brunswick, New Jersey, United States

NYU Langone Medical Center - NYU Medical Oncology Associates

🇺🇸

New York, New York, United States

Columbia University

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

Duke Children's Hospital and Health Center

🇺🇸

Durham, North Carolina, United States

Wake Forest University Baptist Health

🇺🇸

Winston-Salem, North Carolina, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Virginia Mason Medical Center

🇺🇸

Seattle, Washington, United States

Froedtert Hospital and the Medical College of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Sun Yat-sen University Cancer Center

🇨🇳

Guangzhou, Guangdong, China

Henan Cancer Hospital

🇨🇳

Zhengzhou, Henan, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

🇨🇳

Shanghai, Shanghai, China

Site FR33005

🇫🇷

Vaillant, Villejuif, France

Site FR33003

🇫🇷

Lyon Cedex 08, France

Site FR33004

🇫🇷

Marseille, France

Site FR33001

🇫🇷

Saint-Herblain, France

Site FR33002

🇫🇷

Toulouse, France

Site IT39001

🇮🇹

Milano, Italy

Site IT39005

🇮🇹

Rozzano, Italy

Site IT39003

🇮🇹

Verona, Italy

Aichi Cancer Center

🇯🇵

Nagoya, Aichi, Japan

National Cancer Center Hospital East

🇯🇵

Kashiwa, Chiba, Japan

Kanagawa Cancer Center

🇯🇵

Yokohama, Kanagawa, Japan

Kindai University Hospital

🇯🇵

Osakasayama, Osaka, Japan

Osaka University Hospital

🇯🇵

Suita, Osaka, Japan

National Cancer Center Hospital

🇯🇵

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

🇯🇵

Koto-ku, Tokyo, Japan

Site KR82004

🇰🇷

Seongnam-si, Gyeonggi-do, Korea, Republic of

Related News

drugs.com
·

FDA Approves Vyloy (zolbetuximab-clzb) for the Treatment of Advanced Gastric and GEJ Cancer

FDA approves Vyloy (zolbetuximab-clzb) for first-line treatment of advanced HER2-negative gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors. Vyloy is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival.
pipelinereview.com
·

Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced ...

Astellas announces FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced HER2-negative gastric/gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors, based on SPOTLIGHT and GLOW trials. VYLOY is the first CLDN18.2-targeted therapy in the U.S.
prnewswire.com
·

Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced ...

Astellas announces FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer, based on SPOTLIGHT and GLOW trials. VYLOY is the first CLDN18.2-targeted therapy in the U.S.
biospace.com
·

Astellas Receives Approval from the European Commission for VYLOY™ (zolbetuximab) in ...

European Commission approves VYLOY™ (zolbetuximab) for first-line treatment of advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors, extending progression-free and overall survival in Phase 3 trials.
prnewswire.com
·

Astellas Receives Approval from the European Commission for VYLOY™ (zolbetuximab) in ...

Astellas announces EC approval of VYLOY™ (zolbetuximab) for HER2-negative gastric/GEJ adenocarcinoma with CLDN18.2 positivity, extending PFS and OS in Phase 3 trials. Zolbetuximab is the first and only CLDN18.2-targeted therapy in the EU.
  • Prev
  • 1
  • 2
  • Next
© Copyright 2024. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy