NCT05101070

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	S-531011	Administered by intravenous infusion
DRUG	Pembrolizumab	Administered by intravenous infusion
DRUG	Bevacizumab	Administered by intravenous infusion

Timeline

• Start date: 2022-05-30
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2021-11-01
• Last updated: 2026-03-18

Locations

8 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study