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NCT03637764 · ClinicalTrials.gov registry record · Phase 1
Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT03637764 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 107 participants.
The verdict
NCT03637764, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
Primary Objectives: * Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D). * Phase 2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC. * Phase 2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM. Secondary Objectives: * To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2. * To evaluate the immunogenicity of isatuximab and atezolizumab. * To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab. * To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).
Interventions
- DRUG Atezolizumab
- DRUG Isatuximab SAR650984
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2018-08-06 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03637764
The ClinicalTrials.gov registry entry for NCT03637764 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 107 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 Atezolizumab is the first listed.
NCT03637764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03637764 about?
NCT03637764 is a clinical study titled "Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies". Primary Objectives: * Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resista...
What is the current status of trial NCT03637764?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2018-08-06. Estimated completion is 2022-05-11.
What interventions are being tested in trial NCT03637764?
The interventions under investigation include: Atezolizumab (DRUG), Isatuximab SAR650984 (DRUG).
Who is sponsoring clinical trial NCT03637764?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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