First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT05875168
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

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

Interventions

  • DS-3939a — DRUG
    One IV infusion Q3W on Day 1 of each 21-day cycle

Study Details

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Key Dates

First listed
May 25, 2023
Start date
Aug 18, 2023
Status verified
Aug 2026
Primary completion
Oct 20, 2026
Completion
Feb 15, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation (Part 1)
    Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a starting at 1 mg/kg.
  • Experimental: Dose Expansion (Part 2)
    Multiple expansion cohorts targeting various advanced solid tumors.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a [ Time Frame: Approximately 3 months after first dosing ]

Central Contacts

  • (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
    908-992-6400
    [email protected]
  • (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information
    +81-3-6225-1111 (M-F 9-5 JST)
    [email protected]

Locations (7)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232
Principal Investigator
University of Kansas Medical CenterWestwoodKansas66205-
Oregon Health & Science UniversityPortlandOregon97239-
Rhode Island HospitalProvidenceRhode Island02903
Principal Investigator
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Principal Investigator
The Medical College of Wisconsin, INCMilwaukeeWisconsin53226-

Find similar trials in Sarasota, FL

By research site
Florida Cancer Specialists· Sarasota, FLUniversity of Kansas Medical Center· Westwood, KSOregon Health & Science University· Portland, ORRhode Island Hospital· Providence, RIUniversity of Texas M.D. Anderson Cancer Center· Houston, TXHuntsman Cancer Institute, University of Utah· Salt Lake City, UT

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