Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT04717375. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04717375
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 125 participants
Conditions and interventions
Interventions
- SAR444881 Drug
- Pembrolizumab Drug
- Cetuximab Drug
- Carboplatin Drug
- Pemetrexed Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 11, 2021 (Actual)
- Primary completion
- Jul 2, 2025 (Actual)
- Completion
- Jul 2, 2025 (Actual)
- Last update posted
- Sep 29, 2026
2021 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital- Site Number : 8400003 | Phoenix | Arizona | 85054-4504 | — |
| City of Hope Comprehensive Cancer Center- Site Number : 8400002 | Duarte | California | 91030 | — |
| University of Colorado- Site Number : 8400012 | Aurora | Colorado | 80045 | — |
| Smilow Cancer Center at Yale-New Haven- Site Number : 8400001 | New Haven | Connecticut | 06511 | — |
| Clermont Oncology Center- Site Number : 8400005 | Clermont | Florida | 34711 | — |
| Mid Florida Hematology and Oncology Center- Site Number : 8400006 | Orange City | Florida | 32763 | — |
| Mercy Cancer Center - MercyOne Richard Deming Cancer Center- Site Number : 8400011 | Des Moines | Iowa | 50314 | — |
| Norton Cancer Institute - Downtown Women's Cancer Center- Site Number : 8400004 | Louisville | Kentucky | 40202 | — |
| Mayo Clinic Hospital Rochester- Site Number : 8400007 | Rochester | Minnesota | 55905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04717375, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04717375 live on ClinicalTrials.gov.