Evaluation of SAR408701 in Patients With Advanced Solid Tumors

Summary

Primary Objectives: * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle). * To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1. Secondary Objectives: * To characterize the overall safety profile of SAR408701. * To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. * To identify the recommended phase 2 dose (RP2D) of SAR408701. * To assess the potential immunogenicity of SAR408701.

Timeline

Start

2014-07-23

Primary completion

2020-11-10

Completion

2024-11-19

Publications

• Results Gazzah A, Bedard PL, Hierro C, Kang YK, Abdul Razak A, Ryu MH, Demers B, Fagniez N, Henry C, Hospitel M, Soria JC, Tabernero J. Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study. Ann Oncol. 2022 Apr;33(4):416-425. doi: 10.1016/j.annonc.2021.12.012. Epub 2022 Jan 10.
• Results Tabernero J, Bedard PL, Bang YJ, Vieito M, Ryu MH, Fagniez N, Chadjaa M, Soufflet C, Masson N, Gazzah A. Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens. Cancer Res Commun. 2023 Aug 28;3(8):1662-1671. doi: 10.1158/2767-9764.CRC-23-0284. eCollection 2023 Aug.
• Gazzah A, Ternes N, Lee JS, Wang E, Carene D, Wang H, Masson N, Boitier E, Lartigau A, Mace N, Chadjaa M, Dib C, Nunes M, Muzard G, Longuemaux-Valence S, Bauchet AL. Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. Transl Oncol. 2026 Jan;63:102615. doi: 10.1016/j.tranon.2025.102615. Epub 2025 Dec 3.

Drugs

Indications