NCT04717375

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Estimated Study Duration: Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months

Conditions

• Cancer
• Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-11
• Primary completion: 2025-07-02
• Completion: 2025-07-02
• First posted: 2021-01-22
• Last updated: 2025-08-07

Locations

18 sites across 4 countries: United States, Canada, Israel, United Kingdom

Regulatory

• FDA-regulated drug study