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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: Recruiting Phase 1 study of Solid Tumors, sponsored by Shionogi.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2022-05-30 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
What NCT05101070 shows while recruiting
NCT05101070 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target.
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05101070's enrollment target sits among peer trials
282 19th of 125 higher than 107 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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-
Study of AUBE00 in Patients With Solid Tumors
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