S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT05101070
- Run by
- Shionogi
- People needed
- 282
- Starts
- 2022-05-30
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Cancer Center Hospital — Chuo Ku, Tokyo, Japan (enrolling)
- University of Florida Health — Gainesville, Florida, United States (enrolling)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (enrolling)
- The University of Osaka Hospital — Suita, Osaka, Japan (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Henry Ford Health Center — Detroit, Michigan, United States
- Angeles Clinic and Research Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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