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Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
Sponsor: Sanofi
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
Interventions
SAR444881
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Pembrolizumab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Cetuximab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Carboplatin
Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
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