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A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

PHASE1PHASE2RECRUITING

This study will investigate the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) in combination with pembrolizumab in in microsatellite instability-high/Defective mismatch repair (MSI-H/dMMR) locally advanced unresectable or metastatic gastric /GEJ adenocarcinomas.

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Study details:

This Phase 1b/2 study will be conducted in two parts; a safety lead-in part (Phase 1b) to identify the RP2D of S095029 in combination with pembrolizumab and an expansion part (Phase 2) to evaluate anti-tumor activity and safety in participants with locally advanced unresectable or metastatic MSI-H/dMMR gastric /GEJ adenocarcinomas.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

Has received more than one previous line of treatment in the locally advanced and unresectable or metastatic setting.

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

Participants who have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (shorter interval, at least 5 half-lives, for kinase inhibitors or other short half-life drugs) prior to first study treatment.

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

Major surgery less than 4 weeks prior to the first study treatment or participants who have not recovered from the side effects of the surgery.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-08-31

Primary completion: 2026-06-10

Study completion finish: 2029-06-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06116136

Intervention or treatment

DRUG: S095029

DRUG: pembrolizumab 200 mg (KEYTRUDA ®)

Conditions

• MSI-H/dMMR Gastroesophageal-junction Cancer
• MSI-H/dMMR Gastric Cancer

Image related to MSI-H/dMMR Gastroesophageal-junction Cancer

Condition: MSI-H/dMMR Gastroesophageal-junction Cancer, MSI-H/dMMR Gastric Cancer
DRUG: S095029 and other drugs
Woodville South, South Australia, Australia
Sponsor: Servier Bio-Innovation LLC

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Find a site

Closest Location:

The Queen Elisabeth Hospital

Research sites nearby

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The Queen Elisabeth Hospital
Woodville South, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: S095029 and pembrolizumab 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.	DRUG: S095029 Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: S095029 and pembrolizumab

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.

DRUG: S095029

Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of Dose-Limiting Toxicities (DLTs)	Phase 1b and Phase 2	At the end of Cycle 1 (each cycle is 21 days)
Total Number of Adverse Events (AEs)	Phase 1b and Phase 2	From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays	Phase 1b and Phase 2	From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Discontinuation	Phase 1b and Phase 2	From screening to 90 days after the last dose
Objective Response Rate (ORR)	Phase 2 ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Approximately 2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Duration of Response (DoR)	Phase 1b and Phase 2. The time from the first documentation of complete response (CR) or partial response (PR) until the documented progressive disease (PD) or death, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST).	Approximately 2 years
Progression-Free Survival (PFS)	Phase 1b and Phase 2. The time from the first dose of S095029 to first documented PD or death due to any cause, whichever occurs first, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST).	Approximately 2 years
Disease Control Rate (DCR)	Phase 1b and Phase 2. The proportion of participants who achieved stable disease (SD), PR, or CR (based on participant's best response), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST).	Approximately 2 years
Overall Survival (OS)	Phase 1b and Phase 2. The time from first S095029 dose to death due to any cause.	Approximately 2 years
Trough Concentrations of S095029 (Ctrough)	Phase 1b and Phase 2.	From first dose to 30 days after the last dose
Concentration of potential antibodies directed against S095029	Phase 1b and Phase 2.	From screening to 30 days after the last dose, or end of study if clinically indicated
Objective Response Rate (ORR)	Phase 1b ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per immune Response Evaluation Criteria in Solid Tumors (iRECIST).	Approximately 2 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.