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

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 is a dose escalation, and dose expansion study of T-DXd plus hyaluronidase administered subcutaneously, to assess the safety, tolerability, PK and efficacy of SC T-DXd plus hyaluronidase in participants with metastatic solid tumors.

Key Dates

Start date

Jul 17, 2025

Status verified

Mar 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

• Contact for Trial Information
  908-992-6400
  [email protected]

Locations (6)

Find similar trials in Newport Beach, CA

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