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NCT05101070 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumors, sponsored by Shionogi.

Recruiting
Registry status
Phase 1
Development phase
282
Enrollment target
8
Study locations

NCT05101070 is a Phase 1 study of Solid Tumors that is actively recruiting participants, run by Shionogi. The registered enrollment target is 282 participants, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target. The trial reports 8 study locations across 8 states.

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The verdict

NCT05101070, a Phase 1 study of Solid Tumors, is actively recruiting participants, sponsored by Shionogi.

RECRUITING
Registry status
Phase 1
Development phase
282 participants
Enrollment target
8
Study locations

Study 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 Studied

Solid Tumors

Interventions

  • DRUG Pembrolizumab
  • DRUG Bevacizumab
  • DRUG S-531011

Study Locations (8)

California

  • Angeles Clinic and Research Center - Los Angeles

Florida

  • University of Florida Health - Gainesville

Michigan

  • Henry Ford Health Center - Detroit

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Texas

  • MD Anderson Cancer Center - Houston

Chiba

  • National Cancer Center Hospital East - Kashiwa

Osaka

  • The University of Osaka Hospital - Suita

Tokyo

  • National Cancer Center Hospital - Chuo Ku

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2022-05-30
Est. Completion 2028-05-31
Phase Phase 1

Sponsor

Shionogi

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05101070

The ClinicalTrials.gov registry entry for NCT05101070 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target. The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT05101070 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT05101070 about?

NCT05101070 is a clinical study titled "S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors". 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 ...

What is the current status of trial NCT05101070?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 282 participants. The study started on 2022-05-30. Estimated completion is 2028-05-31.

What conditions does trial NCT05101070 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT05101070?

The interventions under investigation include: Pembrolizumab (DRUG), Bevacizumab (DRUG), S-531011 (DRUG).

Who is sponsoring clinical trial NCT05101070?

This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05101070 being conducted?

This trial has 8 study locations across California, Florida, Michigan, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.