A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies

Part of paid clinical trials in New York, New York.

Sponsor
Daiichi Sankyo
Study ID
NCT07220616
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hematological Malignancies

Eligibility Criteria

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

Interventions

  • DS3790a — DRUG
    Administered as specified in the protocol
  • Combination drug — DRUG
    Administered as specified in the protocol
  • Combination drug — DRUG
    Administered as specified in the protocol

Study Details

This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.

Key Dates

Start date
Jan 16, 2026
Status verified
May 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Escalation Phase
    Participants with hematological malignancies who received DS3790a monotherapy.
  • Experimental: Monotherapy Dose Expansion Phase
    Participants with hematological malignancies who received DS3790a monotherapy.
  • Experimental: Cohort A Combination Dose-escalation Phase
    Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
  • Experimental: Cohort A Randomization/Optimization Phase
    Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
  • Experimental: Cohort A Phase 2
    Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
  • Experimental: Cohort B Combination Dose-escalation Phase
    Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
  • Experimental: Cohort B Randomization/Optimization Phase
    Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
  • Active Comparator: Standard of Care
    Participants with hematological malignancies who received standard of care (SoC).

Primary Outcome Measure

Number of Participants Reporting Dose-limiting Toxicities, Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and Deaths in Participants With Hematological Malignancies [ Time Frame: Baseline up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteNew YorkNew York10065
Principal Investigator

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By research site
Research Site· New York, NY

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