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Monoclonal Antibodies

S095029 + Pembrolizumab for Stomach Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Servier Bio-Innovation LLC

Eligibility Criteria Checklist

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

Must have

Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma

Participants' tumor must have an MSI-H or dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment.

Must not have

Prior radiotherapy if completed less than 2 weeks before first study treatment

Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmed cell death ligand 1 (PDL1), anti-CTLA4)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test the safety and effectiveness of a new drug called S095029, when used together with pembrolizumab, in treating advanced stomach or gastroesophageal junction cancers that have

Who is the study for?

This trial is for adults with advanced stomach or gastroesophageal junction cancer that can't be removed by surgery. Their tumors must show a high level of microsatellite instability (MSI-H) or defective mismatch repair (dMMR), which are specific genetic features.

What is being tested?

The study tests S095029, an experimental drug targeting immune cells, combined with pembrolizumab, an approved immunotherapy. It aims to assess safety and effectiveness in shrinking or controlling the growth of these cancers.

What are the potential side effects?

Possible side effects include immune-related reactions such as skin rash, diarrhea due to inflammation in the gut, liver inflammation leading to jaundice and fatigue, lung issues causing coughing and shortness of breath.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in the stomach or where the stomach meets the esophagus and cannot be surgically removed.

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My tumor is MSI-H or dMMR as per the tests.

Exclusion Criteria

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

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I finished radiotherapy less than 2 weeks ago.

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I have been treated with immunotherapy drugs before.

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I haven't taken any cancer drugs or experimental treatments in the last 4 weeks.

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I had major surgery less than 4 weeks ago or am still recovering from its side effects.

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I have had more than one treatment for my advanced or metastatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events (AEs) Leading to Dose Discontinuation

Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays

Number of Dose-Limiting Toxicities (DLTs)

+1 more

Secondary study objectives

Concentration of potential antibodies directed against S095029

Disease Control Rate (DCR)

Duration of Response (DoR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: S095029 and pembrolizumabExperimental Treatment2 Interventions

Participants diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJ), not previously treated with checkpoint inhibitors (CPIs) may first be enrolled into a Phase 1b safety lead-in part which will be used to identify the recommended Phase 2 dose (RP2D) of S095029 in combination with pembrolizumab. During the Phase 2 part, participants will receive the recommended Phase 2 dose (RP2D) of S095029, along with pembrolizumab.

0 / 7Eligibility criteria met