Clinical trialPhase 1 / Phase 2Terminated

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

NCT04717375 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Stopped early. Results posted on ClinicalTrials.gov; not read here yetEarly discontinuation based on strategic sponsor decision not driven by any safety concerns (Business decision)
Phase: Phase 1 / Phase 2
Status: Terminated
Study type: Interventional
Start: 11 April 2021
Ended: 2 July 2025
Enrollment: 125 participants
Sites: 18
Primary outcomes: Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs); Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Dose Limiting Toxicities (DLTs); Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1 and Sub-Part 2B: Stage 1 Cohort D1: Objective Response Rate (ORR)
Sponsor type: Industry
Results posted: 29 September 2026
Last update: 29 September 2026

These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.

Results posted on ClinicalTrials.gov; not read here yet. See them at the registry ↗

Ask this document

Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.

Try

Source text

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment (considering maximum duration of treatment exposure) i.e., up to approximately Part 1-Sub-Part 1A: 51 weeks, Sub-Part 1B: 126.7 weeks, Sub-Part 1C: 99.3 weeks]. Count Of Participants, Participants. TEAEs: Part 1: Sub-Part 1A: Cohort 1: SAR444881 0.1 mg/kg (n=5): 5; Part 1: Sub-Part 1A: Cohort 2: SAR444881 0.3 mg/kg (n=3): 3; Part 1: Sub-Part 1A: Cohort 3: SAR444881 1 mg/kg (n=3): 3; Part 1: Sub-Part 1A: Cohort 4: SAR444881 3 mg/kg (n=7): 7; Part 1: Sub-Part 1A: Cohort 5: SAR444881 10 mg/kg (n=7): 6; Part 1: Sub-Part 1A: Cohort 6: SAR444881 20 mg/kg (n=6): 6; Part 1: Sub-Part 1B: SAR444881 1 mg/kg + Pembrolizumab (n=4): 4; Part 1: Sub-Part 1B: SAR444881 3 mg/kg + Pembrolizumab (n=7): 7; Part 1: Sub-Part 1B: SAR444881 10 mg/kg + Pembrolizumab (n=6): 6; Part 1: Sub-Part 1B: SAR444881 20 mg/kg + Pembrolizumab (n=6): 6; Part 1: Sub-Part 1C: SAR444881 1 mg/kg + Cetuximab (n=3): 3; Part 1: Sub-Part 1C: SAR444881 3 mg/kg + Cetuximab (n=6): 6; Part 1: Sub-Part 1C: SAR444881 10 mg/kg + Cetuximab (n=6): 6; Part 1: Sub-Part 1C: SAR444881 20 mg/kg + Cetuximab (n=7): 7. TESAEs: Part 1: Sub-Part 1A: Cohort 1: SAR444881 0.1 mg/kg (n=5): 1; Part 1: Sub-Part 1A: Cohort 2: SAR444881 0.3 mg/kg (n=3): 0; Part 1: Sub-Part 1A: Cohort 3: SAR444881 1 mg/kg (n=3): 1; Part 1: Sub-Part 1A: Cohort 4: SAR444881 3 mg/kg (n=7): 0; Part 1: Sub-Part 1A: Cohort 5: SAR444881 10 mg/kg (n=7): 2; Part 1: Sub-Part 1A: Cohort 6: SAR444881 20 mg/kg (n=6): 2; Part 1: Sub-Part 1B: SAR444881 1 mg/kg + Pembrolizumab (n=4): 2; Part 1: Sub-Part 1B: SAR444881 3 mg/kg + Pembrolizumab (n=7): 1; Part 1: Sub-Part 1B: SAR444881 10 mg/kg + Pembrolizumab (n=6): 0; Part 1: Sub-Part 1B: SAR444881 20 mg/kg + Pembrolizumab (n=6): 1; Part 1: Sub-Part 1C: SAR444881 1 mg/kg + Cetuximab (n=3): 1; Part 1: Sub-Part 1C: SAR444881 3 mg/kg + Cetuximab (n=6): 1; Part 1: Sub-Part 1C: SAR444881 10 mg/kg + Cetuximab (n=6): 1; Part 1: Sub-Part 1C: SAR444881 20 mg/kg + Cetuximab (n=7): 1.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Part 1: Sub-Parts 1A, 1B and 1C: Number of Participants With Dose Limiting Toxicities (DLTs) [Up to 28 days following the administration of study treatment (Day 1 of Cycle 1, at any dose)]. Count Of Participants, Participants. Part 1: Sub-Part 1A: Cohort 1: SAR444881 0.1 mg/kg (n=5): 0; Part 1: Sub-Part 1A: Cohort 2: SAR444881 0.3 mg/kg (n=3): 0; Part 1: Sub-Part 1A: Cohort 3: SAR444881 1 mg/kg (n=3): 0; Part 1: Sub-Part 1A: Cohort 4: SAR444881 3 mg/kg (n=7): 0; Part 1: Sub-Part 1A: Cohort 5: SAR444881 10 mg/kg (n=7): 0; Part 1: Sub-Part 1A: Cohort 6: SAR444881 20 mg/kg (n=6): 0; Part 1: Sub-Part 1B: SAR444881 1 mg/kg + Pembrolizumab (n=4): 0; Part 1: Sub-Part 1B: SAR444881 3 mg/kg + Pembrolizumab (n=7): 0; Part 1: Sub-Part 1B: SAR444881 10 mg/kg + Pembrolizumab (n=6): 0; Part 1: Sub-Part 1B: SAR444881 20 mg/kg + Pembrolizumab (n=6): 0; Part 1: Sub-Part 1C: SAR444881 1 mg/kg + Cetuximab (n=3): 0; Part 1: Sub-Part 1C: SAR444881 3 mg/kg + Cetuximab (n=6): 0; Part 1: Sub-Part 1C: SAR444881 10 mg/kg + Cetuximab (n=6): 0; Part 1: Sub-Part 1C: SAR444881 20 mg/kg + Cetuximab (n=7): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Part 2: Sub-Part 2A: Stage 1 Cohorts C1 and E1 and Sub-Part 2B: Stage 1 Cohort D1: Objective Response Rate (ORR) [From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, i.e., approximately 36 weeks for Cohort C1, 25 weeks for Cohort E1 and 33 weeks for Cohort D1]. Number, percentage of participants (95% Confidence Interval). Part 2: Sub-Part 2A: Stage 1 Cohort C1: SAR444881 10 mg/kg + Cetuximab (n=20): 5 (0.1 to 24.9); Part 2: Sub-Part 2A: Stage 1 Cohort E1: SAR444881 10 mg/kg + Cetuximab (n=10): 0 (0 to 30.8); Part 2: Sub-Part 2B: Stage 1 Cohort D1: SAR444881 10 mg/kg (n=19): 0 (0 to 17.6).