A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT05584670. 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, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors. The study will include 2 parts: A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable. A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable. Approximately 542 participants will be exposed to the study intervention: * approximately 123 participants in part 1, * up to 410 participants in expansion/dose optimization part (part 2) * and up to 9 participants in Japan cohort F.
Study identification
- NCT ID
- NCT05584670
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 542 participants
Conditions and interventions
Conditions
Interventions
- SAR445877 Drug
- Cetuximab Drug
- ADG126 Drug
- Bevacizumab Drug
- Nivolumab Drug
- Ipilimumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 28, 2022
- Primary completion
- Jan 18, 2027
- Completion
- Jun 27, 2028
- Last update posted
- Jun 22, 2026
2022 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Christiana Care Health System - Newark- Site Number : 8400011 | Newark | Delaware | 19718 | Recruiting |
| University of Iowa- Site Number : 8400014 | Iowa City | Iowa | 52242 | Recruiting |
| The University of Kansas Cancer Center - Westwood- Site Number : 8400008 | Westwood | Kansas | 66205 | Recruiting |
| Karmanos Cancer Institute - Detroit- Site Number : 8400006 | Detroit | Michigan | 48201 | Recruiting |
| John Theurer Cancer Center- Site Number : 8400001 | Hackensack | New Jersey | 07601 | Recruiting |
| NYU Langone Medical Center- Site Number : 8400013 | New York | New York | 10016 | Recruiting |
| Rhode Island Hospital - Providence - Eddy Street- Site Number : 8400004 | Providence | Rhode Island | 02905 | Recruiting |
| The University of Texas MD Anderson Cancer Center- Site Number : 8400005 | Houston | Texas | 77030 | Recruiting |
| Fred Hutchinson Cancer Center- Site Number : 8400010 | Seattle | Washington | 98109 | Recruiting |
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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05584670, 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 Jun 22, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05584670 live on ClinicalTrials.gov.