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

NCT07015697 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-03-20

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent or Metastatic Solid Tumors

Interventions

DRUG

Trastuzumab Deruxtecan

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015697 on ClinicalTrials.gov