Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06116136 | A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers. | PHASE1 | ACTIVE NOT_RECRUITING | 48 | — | — | Aug 31, 2024 | Aug 1, 2027 | Apr 3, 2026 | 49 | United States, Australia +13 |
Phase 1b and Phase 2
Phase 1b and Phase 2
Phase 1b and Phase 2
Phase 1b and Phase 2
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.
| Arm | Type | Description |
|---|---|---|
| S095029 and pembrolizumab | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| S095029 | DRUG | Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W). |
| pembrolizumab 200 mg (KEYTRUDA ®) | DRUG | Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W). |
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/dMMR status according to institutional guidelines and/or according to the College of American Pathologist...