A Study of DS5361b in Participants With Advanced Solid Tumors

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT07182591
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DS5361b — DRUG
    Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE. Dose Expansion Part: DS5361b will be administered at RDE.
  • Pembrolizumab — DRUG
    Dose Escalation Part: Pembrolizumab will be administered at a standard dose. Dose Expansion Part: Pembrolizumab will be administered at a standard dose.

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
May 2026
Primary completion
Mar 18, 2030
Completion
Dec 3, 2030

Study Design

Enrollment
192 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Monotherapy (Dose Escalation)
    Participants will receive DS5361b at escalating doses.
  • Experimental: Part 2: Combination Therapy (Dose Escalation)
    Participants will receive DS5361b at escalating doses in combination with Pembrolizumab.
  • Experimental: Part 3: Combination Therapy (Dose Expansion)
    Participants will receive DS5361b in combination with Pembrolizumab at the recommended dose for expansion (RDE).

Primary Outcome Measure

Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1: Day 1 up to Day 21 (each cycle is 21 days) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteSarasotaFlorida34232-
Research SiteProvidenceRhode Island02903-
Research SiteIrvingTexas75039-
Research SiteSan AntonioTexas78229-
Research SiteFairfaxVirginia22031-

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