Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Lead Sponsor:
Servier Bio-Innovation LLC
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Institut de Recherches Internationales Servier
Conditions:
MSI-H/dMMR Gastroesophageal-junction Cancer
MSI-H/dMMR Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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 ant...
Eligibility Criteria
Inclusion
- Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
- Participants' tumor must have an MSI-H/dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment.
Exclusion
- 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.
Key Trial Info
Start Date :
August 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06116136
Start Date
August 31 2024
End Date
August 1 2026
Last Update
October 14 2025
Active Locations (49)
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1
Ocala Oncology Center Pl
Ocala, Florida, United States, 34474
2
Investigative Clinical Research of Indiana, Llc
Noblesville, Indiana, United States, 46062
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
The Queen Elizabeth Hospital
Woodville South, Australia, 5011