NCT03324113

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: * To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors. Secondary Objectives: * To characterize the overall safety profile of SAR408701 monotherapy. * To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites. * To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part. * To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity. * To assess the potential immunogenicity of SAR408701.

Detailed description

The study duration per participant will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an End-of-Treatment (EOT) visit around 30 days after the last administration of IMP, and at least one follow-up (FU) visit after the EOT visit.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR408701	Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUG	dexamethasone	Pharmaceutical form: solution for eye drop Route of administration: eye drop
DRUG	naphazoline	Pharmaceutical form: solution for eye drop Route of administration: eye drop
DRUG	diphenhydramine	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2017-10-17
• Primary completion: 2022-11-18
• Completion: 2022-12-26
• First posted: 2017-10-27
• Last updated: 2025-08-05

Locations

3 sites across 1 country: Japan