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Study identifier: NCT05101070 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Solid Tumors  ·  Sponsor: Shionogi

PhasePhase 1/Phase 2
Planned participants282
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Shionogi Clinical Trials Administrator Clinical Support Help Line  ·  800-849-9707  ·  Shionogiclintrials-admin@shionogi.co.jp

Always discuss trial participation with your own doctor first.

Locations (8)

Angeles Clinic and Research CenterLos Angeles, California, United StatesActive Not Recruiting
University of Florida HealthGainesville, Florida, United StatesRecruiting
Henry Ford Health CenterDetroit, Michigan, United StatesActive Not Recruiting
Fox Chase Cancer CenterPhiladelphia, Pennsylvania, United StatesRecruiting
MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
National Cancer Center Hospital EastKashiwa, Chiba, JapanRecruiting
The University of Osaka HospitalSuita, Osaka, JapanRecruiting
National Cancer Center HospitalChuo Ku, Tokyo, JapanRecruiting

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Source record: clinicaltrials.gov/study/NCT05101070