A Phase 1b/2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Shionogi
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 c…
Interventions
- DrugS-531011
Administered by intravenous infusion
- DrugPembrolizumab
Administered by intravenous infusion
- DrugBevacizumab
Administered by intravenous infusion
Locations (8)
- Angeles Clinic and Research CenterLos Angeles, California
- University of Florida HealthGainesville, Florida
- Henry Ford Health CenterDetroit, Michigan
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- MD Anderson Cancer CenterHouston, Texas
- National Cancer Center Hospital EastKashiwa, Chiba