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NCT07182591 · ClinicalTrials.gov registry record · Phase 1

A Study of DS5361b in Participants With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumor, sponsored by Daiichi Sankyo.

Recruiting
Registry status
Phase 1
Development phase
192
Enrollment target
7
Study locations

NCT07182591: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by Daiichi Sankyo.

NCT07182591 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 192 participants, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target. The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07182591, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Daiichi Sankyo.

RECRUITING
Registry status
Phase 1
Development phase
192 participants
Enrollment target
7
Study locations

Study Summary

This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.

Primary Outcome

A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3.

Conditions Studied

Advanced Solid Tumor

Interventions

  • DRUG Pembrolizumab
  • DRUG DS5361b

Study Locations (7)

Texas

  • Research Site - Irving
  • Research Site - San Antonio

Other

  • Research Site - Chiba
  • Research Site - Kōtoku

Florida

  • Research Site - Sarasota

Rhode Island

  • Research Site - Providence

Virginia

  • Research Site - Fairfax

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2025-10-02
Est. Completion 2030-12-03
Phase Phase 1
Daiichi Sankyo

236 total trials

What NCT07182591 shows while recruiting

NCT07182591 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT07182591 lists 7 locations in 5 states (Texas, Other, Florida).

Frequently Asked Questions

What is clinical trial NCT07182591 about?

NCT07182591 is a clinical study titled "A Study of DS5361b in Participants With Advanced Solid Tumors". This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.

What is the current status of trial NCT07182591?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 192 participants. The study started on 2025-10-02. Estimated completion is 2030-12-03.

What conditions does trial NCT07182591 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT07182591?

The interventions under investigation include: Pembrolizumab (DRUG), DS5361b (DRUG).

Who is sponsoring clinical trial NCT07182591?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07182591 being conducted?

This trial has 7 study locations across Florida, Rhode Island, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

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 NCT07182591's enrollment target sits among peer trials

192 70th of 189 higher than 120 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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More recruiting context for NCT07182591

Source: ClinicalTrials.gov NCT07182591, the US trial registry maintained by the National Library of Medicine. NCT07182591 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.