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Evaluation of SAR408701 in Patients With Advanced Solid Tumors

NCT02187848 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Neoplasm Malignant

Interventions

DRUG

SAR408701

Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-23
Primary Completion
2020-11-10
Completion
2024-11-19

Countries

  • United States
  • Canada
  • France
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02187848 on ClinicalTrials.gov