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NCT03871348 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT03871348: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT03871348 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03871348, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
Primary Objectives: * Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. * Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma. Secondary Objectives: * To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab. * To assess the immunogenicity of SAR441000. * To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab. * To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000. * To determine the recommended dose of SAR441000 for the expansion phase.
Primary Outcome
Incidence of DLTs at Cycle 1 (SAR441000 monotherapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression
Interventions
- DRUG Cemiplimab REGN2810
- DRUG SAR441000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2019-01-03 |
| Est. Completion | 2024-02-21 |
| Phase | Phase 1 |
Why NCT03871348 stopped before completion
NCT03871348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab REGN2810 is the first listed.
NCT03871348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03871348 about?
NCT03871348 is a clinical study titled "A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors". Primary Objectives: * Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standar...
What is the current status of trial NCT03871348?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2019-01-03. Estimated completion is 2024-02-21.
What interventions are being tested in trial NCT03871348?
The interventions under investigation include: Cemiplimab REGN2810 (DRUG), SAR441000 (DRUG).
Who is sponsoring clinical trial NCT03871348?
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 NCT03871348's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 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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