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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 77 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03871348
The ClinicalTrials.gov registry entry for NCT03871348 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab REGN2810 is the first listed.
NCT03871348 reports 0 study locations.
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.
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