Trials / Recruiting
RecruitingNCT07015697
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-07-17
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2025-06-11
- Last updated
- 2026-03-20
Locations
26 sites across 6 countries: United States, France, Japan, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07015697. Inclusion in this directory is not an endorsement.