Evaluation of SAR408701 in Patients With Advanced Solid Tumors

Neoplasm Malignant Clinical Trial

Official title: A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The study duration for an individual patient will start from the signature of the informed consent, 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 visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visits may be required until resolution or stabilization of adverse events (at least 30 days). Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumor treatment or death, whichever comes first. ;

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

• NCT number: NCT02187848
• Study type: Interventional
• Source: Sanofi
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 23, 2014
• Completion date: August 30, 2024