First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Daiichi Sankyo
Study ID
NCT06644755
Phase
PHASE1
Status
Recruiting
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Conditions

  • Sarcoma
  • Solid Tumors

Eligibility Criteria

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

Interventions

  • DS-2243a — DRUG
    Escalation Part: DS-2243a will be administered at escalating doses to determine the RDE Expansion Part: DS-2243a will be administered at RDE

Study Details

This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.

Key Dates

Start date
Nov 14, 2024
Status verified
Jul 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation DS-2243a
    Participants will receive DS-2243a at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.
  • Experimental: Part 2: Dose Expansion SS/MRCLS
    Participants with synovial sarcoma or myxoid/round cell liposarcoma will receive DS-2243a at the recommended dose for expansion (RDE)
  • Experimental: Part 2: Dose Expansion Sq-NSCLC
    Participants with squamous cell carcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)
  • Experimental: Part 2: Dose Expansion UC
    Participants with urothelial carcinoma will receive DS-2243a at the recommended dose for expansion (RDE)
  • Experimental: Part 2: Dose Expansion Ad-NSCLC
    Participants with adenocarcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)

Primary Outcome Measure

Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a [ Time Frame: Up to 18 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MADavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center· New York, NYSarah Cannon Research Institute· Nashville, TN

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