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A Study of DS5361b in Participants With Advanced Solid Tumors
NCT07182591 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2025-10-02 |
| Est. Completion | 2030-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07182591
The ClinicalTrials.gov registry entry for NCT07182591 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07182591 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Texas, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07182591?
The interventions under investigation include: Pembrolizumab (DRUG), DS5361b (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07182591?
This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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