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NCT04000282 · ClinicalTrials.gov registry record · Phase 1
First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT04000282 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 37 participants.
The verdict
NCT04000282, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
Primary Objectives: * Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B * Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM Secondary Objectives: * To characterize the safety profile of SAR442085 * To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent * To evaluate the potential immunogenicity of SAR442085 * To assess preliminary evidence of antitumor activity in the Dose Escalation Part A
Interventions
- DRUG SAR442085
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2023-09-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04000282
The ClinicalTrials.gov registry entry for NCT04000282 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 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 1 intervention - of which SAR442085 is the first listed.
NCT04000282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04000282 about?
NCT04000282 is a clinical study titled "First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma". Primary Objectives: * Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B * Dose Expan...
What is the current status of trial NCT04000282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2019-08-19. Estimated completion is 2023-09-04.
What interventions are being tested in trial NCT04000282?
The interventions under investigation include: SAR442085 (DRUG).
Who is sponsoring clinical trial NCT04000282?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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