First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors

Sponsor
Daiichi Sankyo
Study ID
NCT07681882
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Unresectable Solid Tumor

Eligibility Criteria

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

Interventions

  • DS1025a — DRUG
    Administered on Day 1

Study Details

This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.

Key Dates

First listed
Jul 2, 2026
Start date
Aug 3, 2026
Status verified
Jul 2026
Primary completion
Jan 21, 2028
Completion
Jan 21, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: DS1025a
    Participants with advanced, metastatic, or unresectable solid tumors will receive DS1025a on Day 1.

Primary Outcome Measure

Number of Participants Reporting Dose-limiting Toxicities (DLTs) [ Time Frame: Day 1 up to approximately 12 months ]

Central Contacts

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