Protocol #: 17-288
Status
Recruiting
Description
Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) - To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) - To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) - To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and cemiplimab combination therapy) - To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: - Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. - Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) - Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab. - Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) - Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP and safety in combination with cemiplimab in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 or anti-PD-L1 and patients with mesenchymal Colorectal cancer. - PFS, duration of response (DOR) and safety in adult patients with metastatic urothelial cancer. - To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.
Condition
Malignant Solid Tumor
Interventions
SAR439459
Cemiplimab REGN2810
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Incidence of Dose Limiting Toxicities (DLTs)
Objective Response Rate (ORR) for Part 2B
Secondary Outcome:
Overall safety profile
Progression free survival (PFS)
Time to progression (TTP)
Objective Response Rate (ORR) Part 2A
Duration of response Part 2B (urothelial cancer cohort only)
Immunogenicity evaluation
Cmax for SAR439459 and for cemiplimab
AUC for SAR439459
AUC0-tau for SAR439459 and for cemiplimab
t1/2z for SAR439459
CL for SAR439459
Vss for SAR439459
Estimated Enrollment
225
Study Start Date
June 9, 2017
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Sanofi
Information Provided By
Sanofi
Official Title
A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors
Clinicaltrials.gov Identifier
NCT03192345

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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