Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Capecitabine

Leucovorin

Levoleucovorin

Oxaliplatin

Folic Acid

Mitogens

Folinic Acid

Folate

Vitamin B9

intravenous infusion

mFOLFOX6 or CAPOX (used at physician discretion) will be used in combination with zolbetuximab

zolbetuximab

Astellas Global Development, Inc.

Medical Director

This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). People will work with their doctor to see if they are capable of being treated with zolbetuximab while they receive other standard medicines to treat their cancer. The program will allow people early access to zolbetuximab before the drug is fully approved.

Zolbetuximab will be given through a vein. This is called an infusion. The infusion will happen during a person's treatment with other cancer medicines. Zolbetuximab will be given every 3 weeks. People will continue treatment until: they have medical problems (unwanted side effects) from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.

People will visit the clinic on certain days during their treatment. During these visits, the program doctors will check for any medical problems (unwanted side effects) from zolbetuximab, other cancer treatment, or both. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood samples will be taken.

People will visit the clinic within 7 days after stopping treatment. The program doctors will check for any medical problems (unwanted side effects) from zolbetuximab or their cancer treatment. Other checks will include a medical examination, laboratory tests, and vital signs. Then, people will have a follow-up visit about 30 days after stopping treatment. If people are having no health problems, the follow-up visit can happen over the telephone.

Early Access Program for Zolbetuximab

A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Astellas Pharma Global Development, Inc.

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Fluorouracil

Nivolumab

Bemarituzumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).

Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle.

Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.

Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle.

Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.

Bemarituzumab will be administered as intravenous (IV) infusion.

Nivolumab will be administered as IV infusion.

mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion.

OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.

Chemotherapy

Placebo will be administered as IV infusion.

Placebo

Amgen Call Center

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.

The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

This is a Phase 1b/3 study:

* Phase 1b (Part 1) is a single-arm open-label study, which will enroll about 20 participants
* Phase 3 (Part 2) is a randomized double-blind 2-arm study, which will enroll 508 participants

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Amgen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Access Program for Zolbetuximab	NCT06048081	Locally Advance... Locally Advance... Metastatic Gast... Metastatic Gast...	zolbetuximab	18 Years -	Astellas Pharma Inc
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer	NCT05111626	Gastric Cancer Gastroesophagea...	Bemarituzumab Nivolumab Chemotherapy Placebo	18 Years - 100 Years	Amgen
Early Access Program for Zolbetuximab	NCT06048081	Locally Advance... Locally Advance... Metastatic Gast... Metastatic Gast...	zolbetuximab	18 Years -	Astellas Pharma Inc
Early Access Program for Zolbetuximab	NCT06048081	Locally Advance... Locally Advance... Metastatic Gast... Metastatic Gast...	zolbetuximab	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for capecitabine and oxaliplatin (capox)