NCT04659603

Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) * For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: * To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine * To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine * To assess the immunogenicity of tusamitamab ravtansine * To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination

Detailed description

The expected duration of study intervention for participants may vary, based on progression date and the cohort; median expected duration of study per participant is estimated at 8 months for Cohort A/C and 6 months for Cohort B (up to 1 month for screening, a median of 4 or 2 months for treatment in Cohort A/C and Cohort B respectively, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).

Conditions

• Breast Cancer Metastatic
• Pancreatic Carcinoma Metastatic

Interventions

Type	Name	Description
DRUG	tusamitamab ravtansine	Pharmaceutical form:Concentrated solution for IV; Route of administration: IV infusion
DRUG	Gemcitabine	Pharmaceutical form: Lyophilized powder for reconstitution or as a solution for infusion; Route of administration: IV infusion

Timeline

• Start date: 2021-03-29
• Primary completion: 2024-02-16
• Completion: 2025-01-19
• First posted: 2020-12-09
• Last updated: 2025-10-01
• Results posted: 2025-03-25

Locations

29 sites across 10 countries: United States, Argentina, Chile, Hungary, Netherlands, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study