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NCT05013554 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT05013554: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT05013554 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05013554, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Primary Objectives: Part 1 (Dose Escalation) * To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part. * To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration. Part 2 (Dose expansion) • To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Secondary Objectives: Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Part 2 • To determine the safety of SAR443216. Part 1 and 2 * To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration. * To evaluate the immunogenicity of SAR443216 after IV and SC administration. * To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Primary Outcome
Incidence of study dose limiting toxicities (DLTs)
Interventions
- DRUG SAR443216 IV
- DRUG SAR443216 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2024-01-15 |
| Phase | Phase 1 |
Why NCT05013554 stopped before completion
NCT05013554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which SAR443216 IV is the first listed.
NCT05013554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05013554 about?
NCT05013554 is a clinical study titled "Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors". Primary Objectives: Part 1 (Dose Escalation) * To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation...
What is the current status of trial NCT05013554?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2021-08-16. Estimated completion is 2024-01-15.
What interventions are being tested in trial NCT05013554?
The interventions under investigation include: SAR443216 IV (DRUG), SAR443216 SC (DRUG).
Who is sponsoring clinical trial NCT05013554?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05013554's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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