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NCT03192345 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 161
- Enrollment target
NCT03192345 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 161 participants.
The verdict
NCT03192345, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 161 participants
- Enrollment target
Study Summary
Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) * To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) * To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) * To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and cemiplimab combination therapy) * To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: * Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. * Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) * Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab. * Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) * Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab. * To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.
Interventions
- DRUG Cemiplimab REGN2810
- BIOLOGICAL SAR439459
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2017-06-09 |
| Est. Completion | 2022-01-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03192345
The ClinicalTrials.gov registry entry for NCT03192345 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 161 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.
NCT03192345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03192345 about?
NCT03192345 is a clinical study titled "A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors". Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) * To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cem...
What is the current status of trial NCT03192345?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 161 participants. The study started on 2017-06-09. Estimated completion is 2022-01-17.
What interventions are being tested in trial NCT03192345?
The interventions under investigation include: Cemiplimab REGN2810 (DRUG), SAR439459 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03192345?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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