S095029
DrugParticipants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).
NCT Number: NCT06116136
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
The Queen Elizabeth Hospital, Woodville South, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).
Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1b and Phase 2
Time frame: From screening to 90 days after the last dose
Phase 1b and Phase 2
Time frame: From screening to 90 days after the last dose
Phase 1b and Phase 2
Time frame: From screening to 90 days after the last dose
Phase 1b and Phase 2
Time frame: Approximately 2 years
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.
Time frame: Approximately 2 years
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).
Time frame: Approximately 2 years
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).
Time frame: Approximately 2 years
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).
Time frame: Approximately 2 years
Phase 1b and Phase 2. The time from first S095029 dose to death due to any cause.
Time frame: From first dose to 30 days after the last dose
Phase 1b and Phase 2.
Time frame: From screening to 30 days after the last dose, or end of study if clinically indicated
Phase 1b and Phase 2.
Time frame: Approximately 2 years
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).
Servier Bio-Innovation LLC
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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