A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

Part of paid clinical trials in Newport Beach, California.

Sponsor
Daiichi Sankyo
Study ID
NCT07015697
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • Trastuzumab Deruxtecan — DRUG
    Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE. Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.

Study Details

This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.

Key Dates

First listed
Jun 11, 2025
Start date
Jul 17, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Part 1 (Dose Escalation)
    Participants will receive Trastuzumab Deruxtecan subcutaneously at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.
  • Experimental: Part 2 (Dose Expansion)
    Participants will receive Trastuzumab Deruxtecan subcutaneously at the recommended dose for expansion (RDE)

Primary Outcome Measure

Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) [ Time Frame: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteNewport BeachCalifornia92663-
Research SiteAtlantaGeorgia30322-
Research SiteLas VegasNevada89169-
Research SiteCharlotteNorth Carolina28204-
Research SiteMaumeeOhio43537-
Research SiteNashvilleTennessee37203-

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