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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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).
Number of Dose-Limiting Toxicities (DLTs)
Phase 1b and Phase 2
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Total Number of Adverse Events (AEs)
Phase 1b and Phase 2
Time frame: From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Phase 1b and Phase 2
Time frame: From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Discontinuation
Phase 1b and Phase 2
Time frame: 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.
Time frame: Approximately 2 years
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).
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ocala Oncology Center Pl
Ocala, Florida, United States
Investigative Clinical Research of Indiana, Llc
Noblesville, Indiana, United States
MD Anderson Cancer Center
Houston, Texas, United States
The Queen Elizabeth Hospital
Woodville South, Australia
Ordensklinikum Linz
Linz, Upper Austria, Austria
Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)
Vienna, Vienna, Austria
Landeskrankenhaus (SALK)
Salzburg, Austria
UZ Leuven Campus Gasthuisberg
Leuven, Belgium
Chu de Liege
Liège, Belgium
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, Brazil
...and 39 more locations
Time frame: 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).
Time frame: Approximately 2 years
Overall Survival (OS)
Phase 1b and Phase 2. The time from first S095029 dose to death due to any cause.
Time frame: Approximately 2 years
Trough Concentrations of S095029 (Ctrough)
Phase 1b and Phase 2.
Time frame: From first dose to 30 days after the last dose
Concentration of potential antibodies directed against S095029
Phase 1b and Phase 2.
Time frame: 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).
Time frame: Approximately 2 years