Trials / Active Not Recruiting
Active Not RecruitingNCT06116136
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Open Label, Non-randomized, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of S095029 (Anti-NKG2A Antibody) as a Part of Combination Therapy in Participants With Locally Advanced and Unresectable or Metastatic MSI-H/dMMR Gastro-esophageal Junction /Gastric Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Servier Bio-Innovation LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 repair (MSI-H/dMMR) locally advanced unresectable or metastatic gastric /GEJ adenocarcinomas.
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 anti-tumor activity and safety in participants with locally advanced unresectable or metastatic MSI-H/dMMR gastric /GEJ adenocarcinomas.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S095029 | Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W). |
| DRUG | pembrolizumab 200 mg (KEYTRUDA ®) | Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W). |
Timeline
- Start date
- 2024-08-31
- Primary completion
- 2027-08-01
- Completion
- 2027-08-01
- First posted
- 2023-11-03
- Last updated
- 2026-04-03
Locations
49 sites across 15 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Hungary, Italy, Japan, Puerto Rico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06116136. Inclusion in this directory is not an endorsement.