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A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
NCT05584670 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Nivolumab
- DRUG Cetuximab
- DRUG SAR445877
- DRUG ADG126
Study Locations (20)
Other
- Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805_Investigational Site Number : 1520007 — Providencia
- Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004 — Recoleta
- Shamir Medical Center_Investigational Site Number : 3760004 — Be’er Ya‘aqov
- Sheba Medical Center - PPDS_Investigational Site Number : 3760003 — Ramat Gan
- Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001 — Tel Aviv
- Investigational Site Number : 3920001 — Kashiwa-Shi
Delaware
- Christiana Care Health System- Site Number : 8400011 — Newark
Iowa
- University of Iowa- Site Number : 8400014 — Iowa City
Kansas
- University of Kansas Cancer Center Clinical Research Center (Fairway) Site Number : 8400008 — Fairway
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit- Site Number : 8400006 — Detroit
New Jersey
- John Theurer Cancer Center Site Number : 8400001 — Hackensack
New York
- NYU Langone Medical Center-New York- 550 1st Ave - BRANY - PPDS- Site Number : 8400013 — New York
Rhode Island
- Rhode Island Hospital Site Number : 8400004 — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 542 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2028-06-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05584670
The ClinicalTrials.gov registry entry for NCT05584670 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 542 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05584670 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Delaware, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05584670 about?
NCT05584670 is a clinical study titled "A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors". 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 ...
What is the current status of trial NCT05584670?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 542 participants. The study started on 2022-11-29. Estimated completion is 2028-06-28.
What conditions does trial NCT05584670 study?
This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05584670?
The interventions under investigation include: Bevacizumab (DRUG), Nivolumab (DRUG), Cetuximab (DRUG), SAR445877 (DRUG), ADG126 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05584670?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05584670 being conducted?
This trial has 20 study locations across Delaware, Iowa, Kansas, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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