A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT05765851
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

  • DS-1103a — DRUG
    One IV infusion Q3W on Day 1 of each 21-day cycle
  • T-DXd — DRUG
    One IV infusion Q3W on Day 1 of each 21-day cycle

Study Details

This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.

Key Dates

Start date
May 30, 2023
Status verified
Jun 2026
Primary completion
May 15, 2030
Completion
May 15, 2030

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: DS-1103a + T-DXd
    Participants with HER2-expressing or HER2-mutated advanced metastatic solid tumors who will receive an escalating intravenous (IV) infusion of DS-1103a (starting dose of 100 mg) every 3 weeks (Q3W) starting on Cycle 1 Day 1. Starting on Cycle 2 Day 1 and on Day 1 of each subsequent cycle, participants will also receive T-DXd IV Q3W.
  • Experimental: Dose Expansion (Cohort 1): DS-1103a + T-DXd
    Participants with a specific HER2-altered advanced solid tumor type who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd IV Q3W starting on Cycle 1 Day 1.
  • Experimental: Dose Expansion (Cohort 2): DS-1103a + T-DXd
    Participants with a specific HER2-altered advanced solid tumor type who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd IV Q3W starting on Cycle 1 Day 1.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicities (Dose Escalation) [ Time Frame: From Cycle 1 Day 1 to Cycle 2 Day 21 (each cycle is 21 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232
Principal Investigator
Lifespan Cancer InstituteProvidenceRhode Island02903
Principal Investigator
University of UtahSalt Lake CityUtah84112-
NEXT OncologyFairfaxVirginia22031
Principal Investigator

Find similar trials in Sarasota, FL

By research site
Florida Cancer Specialists· Sarasota, FLLifespan Cancer Institute· Providence, RIUniversity of Utah· Salt Lake City, UTNEXT Oncology· Fairfax, VA

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