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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: Completed Phase 1 study, sponsored by Sanofi.
NCT03192345 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 161 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of DLTs at Cycle 1 and/or 2 in Parts 1A and 1B.
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 |
What the finished NCT03192345 record still lists
NCT03192345 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (168% higher).
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab REGN2810 is the first listed.
NCT03192345 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03192345's enrollment target sits among peer trials
161 340th of 2000 higher than 1,661 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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