Clinical Trial

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

Study acronym: aCCeleR8-001
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2021-10-28; most recent amendment 2026-03-16.
Status change: Not Yet Recruiting → Recruiting 2022-06-27
Trial Details
NCT Number NCT05101070
Lead Sponsor Shionogi
Collaborators: Merck Sharp & Dohme LLC
Conditions Solid Tumors
Enrollment 282 participants
Start Date 2022-05-30
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-18