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NCT07015697 · ClinicalTrials.gov registry record · Phase 1
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
A Phase 1 study of Recurrent or Metastatic Solid Tumors, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT07015697: Recruiting Phase 1 study of Recurrent or Metastatic Solid Tumors, sponsored by Daiichi Sankyo.
NCT07015697 is a Phase 1 study of Recurrent or Metastatic Solid Tumors that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015697, a Phase 1 study of Recurrent or Metastatic Solid Tumors, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 21 days after the last dose date of trial intervention).
Conditions Studied
Interventions
- DRUG Trastuzumab Deruxtecan
Study Locations (20)
Other
- Research Site Saint - Herblain
- Research Site - Rennes
- Research Site - Chiba
- Research Site - Kanagawa
- Research Site - Tokyo
- Research Site - Tokyo
- Research Site - Tokyo
- Research Site - Seongnam-si
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Barcelona
- Research Site - Madrid
California
- Research Site - Newport Beach
Georgia
- Research Site - Atlanta
Nevada
- Research Site - Las Vegas
North Carolina
- Research Site - Charlotte
Ohio
- Research Site - Maumee
Tennessee
- Research Site - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2025-07-17 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What NCT07015697 shows while recruiting
NCT07015697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 1 condition, with Recurrent or Metastatic Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab Deruxtecan is the first listed.
NCT07015697 names 20 study sites across 7 states, led by Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT07015697 about?
NCT07015697 is a clinical study titled "A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors". 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.
What is the current status of trial NCT07015697?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2025-07-17. Estimated completion is 2028-12-31.
What conditions does trial NCT07015697 study?
This clinical trial studies the following conditions: Recurrent or Metastatic Solid Tumors.
What interventions are being tested in trial NCT07015697?
The interventions under investigation include: Trastuzumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT07015697?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07015697 being conducted?
This trial has 20 study locations across California, Georgia, Nevada, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07015697's enrollment target sits among peer trials
76 706th of 2000 higher than 1,290 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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