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Anti-metabolites

Zolbetuximab + Chemotherapy for Gastric Cancer (Spotlight Trial)

Phase 3

Waitlist Available

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration

Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 23 months

Awards & highlights

Pivotal Trial

Summary

This trial is for patients with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Who is the study for?

Adults with advanced unresectable or metastatic gastric/GEJ cancer that's HER2-negative and expresses Claudin 18.2 proteins can join this trial. They must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants should not be pregnant, breastfeeding, or planning to donate eggs/sperm; contraception is required. Those who've had certain treatments for these cancers within specific timeframes before the study starts cannot participate.

What is being tested?

The trial tests zolbetuximab (IMAB362), which targets Claudin 18.2 on cancer cells, combined with mFOLFOX6 chemotherapy versus a placebo plus mFOLFOX6 in patients with specific gastric cancers. The goal is to see if zolbetuximab helps extend life by preventing cancer progression.

What are the potential side effects?

Zolbetuximab may cause allergic reactions due to its nature as a monoclonal antibody and could lead to immune-related side effects similar to other antibodies used in cancer treatment such as inflammation of organs and infusion reactions. Chemotherapy components like fluorouracil can cause nausea, low blood counts leading to increased infection risk, mouth sores, and neuropathy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to donate sperm from the start of the study until 6 months after the last dose of the study drug.

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My tumor is HER2-negative, confirmed by tests on a stomach or GEJ sample.

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I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.

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My tumor shows high CLDN18.2 expression.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have been diagnosed with stomach or gastroesophageal junction cancer.

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I am not pregnant, confirmed by a test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for HIV or active hepatitis B or C.

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I have been treated for an autoimmune disease in the last 3 months.

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I have had chemotherapy for advanced stomach or GEJ cancer that cannot be surgically removed.

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I have had severe allergic reactions to certain cancer drugs or their ingredients.

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I have severe blockage in my stomach causing vomiting.

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I do not have significant stomach bleeding or untreated ulcers.

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I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.

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I have a serious heart condition.

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My cancer has spread to my brain or spinal cord.

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I need treatment for another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 23 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 23 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Duration Of Response (DOR)

HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire

HRQoL measured by the Global Pain (GP) questionnaire

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (zolbetuximab plus mFOLFOX6)Experimental Treatment4 Interventions

Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.

Group II: Arm B (Placebo plus mFOLFOX6)Placebo Group4 Interventions

Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fluorouracil

1994

Completed Phase 3

~8440

oxaliplatin

2002

Completed Phase 3

~6370