Clinical Trial: NCT04401020
First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
Status:
TERMINATEDPhase:
Phase 1| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2026-09-29 |
Study Overview
Brief 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
Official Title
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
Conditions
Neoplasm Malignant
Intervention / Treatment
- Drug: SAR442257
Other Study ID Numbers
- TED16364
- U1111-1244-2511
- 2019-003390-26
- 2019
Start Date (Actual)
2020-07-24
Primary Completion Date (Actual)
2024-03-02
Study Completion Date (Actual)
2026-05-11
Enrollment (Actual)
47
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2026-09-29 |
Study Overview
Brief 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
Official Title
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
Conditions
Neoplasm Malignant
Intervention / Treatment
- Drug: SAR442257
Other Study ID Numbers
- TED16364
- U1111-1244-2511
- 2019-003390-26
- 2019
Start Date (Actual)
2020-07-24
Primary Completion Date (Actual)
2024-03-02
Study Completion Date (Actual)
2026-05-11
Enrollment (Actual)
47
Study Type
Interventional
Phase
Phase 1