Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05101070
PHASE1/PHASE2

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

Sponsor: Shionogi

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

282

Start Date

2022-05-30

Completion Date

2028-05-31

Last Updated

2026-03-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

S-531011

Administered by intravenous infusion

DRUG

Pembrolizumab

Administered by intravenous infusion

DRUG

Bevacizumab

Administered by intravenous infusion

Locations (8)

Angeles Clinic and Research Center

Los Angeles, California, United States

University of Florida Health

Gainesville, Florida, United States

Henry Ford Health Center

Detroit, Michigan, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan