NCT04401020

First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 relapsed 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 assess preliminary evidence of antitumor activity

Detailed 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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR442257	Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion

Timeline

• Start date: 2020-07-24
• Primary completion: 2024-03-02
• Completion: 2026-03-17
• First posted: 2020-05-26
• Last updated: 2025-03-21

Locations

16 sites across 5 countries: United States, Czechia, Norway, South Korea, Spain

Regulatory

• FDA-regulated drug study