S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D
| Condition(s) | Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab. The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab. |
| Who can participate | Eligibility Criteria: Key Inclusion Criteria: 1. Participants with histologically or cytologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapies with a proven clinical benefit, or who are intolerant to or unwilling to receive these therapies for any reasons. 2. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1. 3. (Part A only) Participants should have 1 of the following tumor types: malignant melanoma, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, or triple-negative breast cancer, esophageal cancer (esophageal squamous cell carcinoma and adenocarcinoma), or gastric cancer (gastric and gastroesophageal juncti |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shionogi |
| Locations | Los Angeles, California, United States; Gainesville, Florida, United States; Detroit, Michigan, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Kashiwa, Chiba, Japan (+2 more sites) |
| Start date | 2022-05-30 |
| NCT ID | NCT05101070 |
| Official listing | https://clinicaltrials.gov/study/NCT05101070 |