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NCT05584670 · ClinicalTrials.gov registry record · Phase 1
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 542
- Enrollment target
- 20
- Study locations
NCT05584670 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Sanofi. The registered enrollment target is 542 participants, above the 219-participant average among 196 other Solid Tumor trials with a reported enrollment target (147% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT05584670, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 542 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 542 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 219-participant average among 196 other Solid Tumor trials with a reported enrollment target (147% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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.
NCT05584670 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Delaware, Iowa.
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.
What interventions are being tested in trial NCT05584670?
The interventions under investigation include: Bevacizumab (DRUG), Nivolumab (DRUG), Cetuximab (DRUG), SAR445877 (DRUG), ADG126 (DRUG).
Who is sponsoring clinical trial NCT05584670?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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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Related
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