An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma
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- STATUS
- Recruiting
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- End date
- Jun 5, 2025
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- participants needed
- 57
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- sponsor
- Sanofi
Summary
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)
Secondary Objectives:
- To characterize the safety profile of SAR442257
- To characterize the pharmacokinetics (PK) profile of SAR442257
- To evaluate the potential immunogenicity of SAR442257
- To assess preliminary evidence of antitumor activity
Description
Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.
Details
| Condition | Neoplasm Malignant |
|---|---|
| Treatment | SAR442257, Acetaminophen or equivalent (premedication), Ranitidine or equivalent (premedication), Diphenhydramine or equivalent (premedication), Montelukast (premedication), Dexamethasone (premedication) |
| Clinical Study Identifier | NCT04401020 |
| Sponsor | Sanofi |
| Last Modified on | 22 October 2022 |
Eligibility
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