drugset / Trial / NCT05101070

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

NCT05101070

Phase 1/2 Recruiting 282 enrolled Shionogi Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-05-30
Primary completion
2028-05-31
Completion
2028-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous
Subject S-531011 Unknown Intravenous

Indications