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TERMINATED
NCT04717375
PHASE1/PHASE2

Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

The study enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy. The study comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 was comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 was composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication were administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 was administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design would be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study was non-randomized except Stage 2 of Sub-Part 2A which would use randomization.

Official title: A Phase 1/2, Dose Escalation, Dose Expansion, and Dose Optimization Study of the Safety, Tolerability, and Anti-tumor Activity of SAR444881 Administered Alone and in Combination With Pembrolizumab, Cetuximab and/or Chemotherapy in Participants With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2021-04-11

Completion Date

2025-07-02

Last Updated

2026-09-29

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

SAR444881

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

Pembrolizumab

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

Cetuximab

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

Carboplatin

Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous

DRUG

Pemetrexed

Pharmaceutical form: Powder for concentrate for solution for infusion or concentrate for solution for infusion; Route of administration: Intravenous

Locations (18)

Mayo Clinic Hospital- Site Number : 8400003

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center- Site Number : 8400002

Duarte, California, United States

University of Colorado- Site Number : 8400012

Aurora, Colorado, United States

Smilow Cancer Center at Yale-New Haven- Site Number : 8400001

New Haven, Connecticut, United States

Clermont Oncology Center- Site Number : 8400005

Clermont, Florida, United States

Mid Florida Hematology and Oncology Center- Site Number : 8400006

Orange City, Florida, United States

Mercy Cancer Center - MercyOne Richard Deming Cancer Center- Site Number : 8400011

Des Moines, Iowa, United States

Norton Cancer Institute - Downtown Women's Cancer Center- Site Number : 8400004

Louisville, Kentucky, United States

Mayo Clinic Hospital Rochester- Site Number : 8400007

Rochester, Minnesota, United States

Investigational Site Number : 1240001

Barrie, Ontario, Canada

Investigational Site Number : 1240003

Sherbrooke, Quebec, Canada

Investigational Site Number : 3760004

Haifa, Israel

Investigational Site Number : 3760005

Jerusalem, Israel

Investigational Site Number : 3760001

Petah Tikva, Israel

Investigational Site Number : 3760003

Ramat Gan, Israel

Investigational Site Number : 3760002

Tel Aviv, Israel

Investigational Site Number : 8260003

London, London, City of, United Kingdom

Investigational Site Number : 8260002

Leeds, United Kingdom