CareAcross

To hear about similar clinical trials, please enter your email below

I agree to receive (at most) monthly updates on similar research. I retain all GDPR rights. CareAcross will never share my email address.

Trial Title: 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

NCT ID: NCT03653507

Condition: 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

Conditions: Official terms:
Adenocarcinoma
Capecitabine
Oxaliplatin

Conditions: Keywords:
CLDN 18.2
gastroesophageal junction cancer
adenocarcinoma
IMAB362
oxaliplatin
HER2
claudiximab
capecitabine
gastric cancer
HER2 Negative
zolbetuximab

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Drug
Intervention name: zolbetuximab
Description: Zolbetuximab will be administered as a minimum 2-hour IV infusion.
Arm group label: Arm A (zolbetuximab plus CAPOX)

Other name: IMAB362

Intervention type: Drug
Intervention name: oxaliplatin
Description: Oxaliplatin will be administered as a 2-hour IV infusion.
Arm group label: Arm A (zolbetuximab plus CAPOX)
Arm group label: Arm B (Placebo plus CAPOX)

Intervention type: Drug
Intervention name: capecitabine
Description: Capecitabine will be administered orally twice daily (bid).
Arm group label: Arm A (zolbetuximab plus CAPOX)
Arm group label: Arm B (Placebo plus CAPOX)

Intervention type: Drug
Intervention name: placebo
Description: Placebo will be administered as a minimum 2-hour IV infusion.
Arm group label: Arm B (Placebo plus CAPOX)

Summary: The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.

Detailed description: The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up. 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Pacific Cancer Care

Address:
City: Monterey
Zip: 93940
Country: United States

Facility:
Name: University of Kansas Cancer Center and Medical Pavilion

Address:
City: Fairway
Zip: 66205
Country: United States

Facility:
Name: Ochsner Clinic CCOP

Address:
City: New Orleans
Zip: 70121
Country: United States

Facility:
Name: New Mexico Oncology Hematology

Address:
City: Albuquerque
Zip: 87109
Country: United States

Facility:
Name: Montefiore Medical Center (MMC)

Address:
City: Bronx
Zip: 10467
Country: United States

Facility:
Name: Weill Cornell Medical College (WCMC)

Address:
City: New York
Zip: 10021
Country: United States

Facility:
Name: Prisma Health Cancer Institute

Address:
City: Boiling Springs
Zip: 29316
Country: United States

Facility:
Name: Parkland Hospital

Address:
City: Dallas
Zip: 75390
Country: United States

Facility:
Name: University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Facility:
Name: Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Utah Cancer Specialist

Address:
City: Salt Lake City
Zip: 84106
Country: United States

Facility:
Name: Site AR54009

Address:
City: Buenos Aires
Country: Argentina

Facility:
Name: Site GB44005

Address:
City: Northwood
Country: Argentina

Facility:
Name: Site AR54006

Address:
City: Pergamino
Country: Argentina

Facility:
Name: Site AR54001

Address:
City: San Miguel De Tucuman
Country: Argentina

Facility:
Name: Site AR54004

Address:
City: San Miguel de Tucumán
Country: Argentina

Facility:
Name: Site AR54003

Address:
City: Viedma
Country: Argentina

Facility:
Name: Site CA15003

Address:
City: Chicoutimi
Country: Canada

Facility:
Name: Site CA15002

Address:
City: Rimouski
Country: Canada

Facility:
Name: Site CA15004

Address:
City: Calgary
Country: Canada

Facility:
Name: Site CN86034

Address:
City: Fuzhou
Country: China

Facility:
Name: Site CN86037

Address:
City: Fuzhou
Country: China

Facility:
Name: Site CN86032

Address:
City: Haikou
Country: China

Facility:
Name: Site CN86012

Address:
City: Zhengzhou
Country: China

Facility:
Name: Site CN86029

Address:
City: Changsha
Country: China

Facility:
Name: Site CN86043

Address:
City: Hengyang
Country: China

Facility:
Name: Site CN86027

Address:
City: Suzhou
Country: China

Facility:
Name: Site CN86046

Address:
City: Wuxi
Country: China

Facility:
Name: Site CN86007

Address:
City: Hangzhou
Country: China

Facility:
Name: Site CN86044

Address:
City: Baoding
Country: China

Facility:
Name: Site CN86035

Address:
City: Beijing
Country: China

Facility:
Name: Site CN86050

Address:
City: Beijing
Country: China

Facility:
Name: Site CN86025

Address:
City: Bengbu
Country: China

Facility:
Name: Site CN86002

Address:
City: Changchun
Country: China

Facility:
Name: Site CN86049

Address:
City: Changchun
Country: China

Facility:
Name: Site CN86053

Address:
City: Changchun
Country: China

Facility:
Name: Site CN86021

Address:
City: Changzhou
Country: China

Facility:
Name: Site CN86039

Address:
City: Chengdu
Country: China

Facility:
Name: Site CN86052

Address:
City: Dalian
Country: China

Facility:
Name: Site CN86054

Address:
City: Dalian
Country: China

Facility:
Name: Site CN86015

Address:
City: Fuzhou
Country: China

Facility:
Name: Site CN86001

Address:
City: Guangzhou
Country: China

Facility:
Name: Site CN86042

Address:
City: Guangzhou
Country: China

Facility:
Name: Site CN86051

Address:
City: Haebrin
Country: China

Facility:
Name: Site CN86036

Address:
City: Hangzhou
Country: China

Facility:
Name: Site CN86038

Address:
City: Linyi
Country: China

Facility:
Name: Site CN86016

Address:
City: Nanjing
Country: China

Facility:
Name: Site CN86045

Address:
City: Nanning
Country: China

Facility:
Name: Site CN86014

Address:
City: Shanghai
Country: China

Facility:
Name: Site CN86026

Address:
City: Shantou
Country: China

Facility:
Name: Site CN86047

Address:
City: Shenyang
Country: China

Facility:
Name: Site CN86017

Address:
City: Shijiazhuang
Country: China

Facility:
Name: Site CN86009

Address:
City: Tianjin
Country: China

Facility:
Name: Site CN86040

Address:
City: Tianjin
Country: China

Facility:
Name: Site CN86031

Address:
City: Urumchi
Country: China

Facility:
Name: Site CN86004

Address:
City: Wuhan
Country: China

Facility:
Name: Site CN86005

Address:
City: Wuhan
Country: China

Facility:
Name: Site CN86013

Address:
City: Xi'an
Country: China

Facility:
Name: Site CN86030

Address:
City: Xiamen
Country: China

Facility:
Name: Site CN86011

Address:
City: Xuzhou
Country: China

Facility:
Name: Site CN86024

Address:
City: Zhengzhou
Country: China

Facility:
Name: Site HR38501

Address:
City: Varazdin
Country: Croatia

Facility:
Name: Site HR38502

Address:
City: Zagreb
Country: Croatia

Facility:
Name: Site HR38503

Address:
City: Zagreb
Country: Croatia

Facility:
Name: Site GR30001

Address:
City: Athens
Country: Greece

Facility:
Name: Site GR30004

Address:
City: Heraklion
Country: Greece

Facility:
Name: Site GR30003

Address:
City: Larissa
Country: Greece

Facility:
Name: Site GR30005

Address:
City: Neo Faliro, Piraeus
Country: Greece

Facility:
Name: Site GR30007

Address:
City: Rio Patras
Country: Greece

Facility:
Name: Site GR30002

Address:
City: Thessaloniki
Country: Greece

Facility:
Name: Site GR3006

Address:
City: Thessaloniki
Country: Greece

Facility:
Name: Site IE35301

Address:
City: Dublin
Country: Ireland

Facility:
Name: Site IE35302

Address:
City: Dublin
Country: Ireland

Facility:
Name: Site JP81007

Address:
City: Fukuoka-shi
Country: Japan

Facility:
Name: Site JP81008

Address:
City: Akashi
Country: Japan

Facility:
Name: Site JP81003

Address:
City: Kawasaki
Country: Japan

Facility:
Name: Site JP81001

Address:
City: Yokohama
Country: Japan

Facility:
Name: Site JP81010

Address:
City: Suita
Country: Japan

Facility:
Name: Site JP81005

Address:
City: Utsunomiya
Country: Japan

Facility:
Name: Site JP81002

Address:
City: Chiba
Country: Japan

Facility:
Name: Site JP81006

Address:
City: Kashiwa
Country: Japan

Facility:
Name: Site JP81004

Address:
City: Kita-gun
Country: Japan

Facility:
Name: Site JP81012

Address:
City: Koto-ku
Country: Japan

Facility:
Name: Site JP81009

Address:
City: Matsuyama
Country: Japan

Facility:
Name: Site JP81011

Address:
City: Tsukiji
Country: Japan

Facility:
Name: Site KR82002

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Site KR82006

Address:
City: Goyang-si
Country: Korea, Republic of

Facility:
Name: Site KR82007

Address:
City: Gyeonggi-do
Country: Korea, Republic of

Facility:
Name: Site KR82014

Address:
City: Incheon
Country: Korea, Republic of

Facility:
Name: Site KR82008

Address:
City: Jeollanam-do
Country: Korea, Republic of

Facility:
Name: Site KR82010

Address:
City: Jeonju-si
Country: Korea, Republic of

Facility:
Name: Site KR82011

Address:
City: Seongnam-si
Country: Korea, Republic of

Facility:
Name: Site KR82001