A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (NCT05584670)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Christiana Care Health System - Newark- Site Number : 8400011 — Newark, Delaware
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- Christiana Care Health System - Newark- Site Number : 8400011 — Newark, Delaware
- University of Iowa- Site Number : 8400014 — Iowa City, Iowa
- The University of Kansas Cancer Center - Westwood- Site Number : 8400008 — Westwood, Kansas
- Karmanos Cancer Institute - Detroit- Site Number : 8400006 — Detroit, Michigan
- John Theurer Cancer Center- Site Number : 8400001 — Hackensack, New Jersey
- NYU Langone Medical Center- Site Number : 8400013 — New York, New York
- Rhode Island Hospital - Providence - Eddy Street- Site Number : 8400004 — Providence, Rhode Island
- The University of Texas MD Anderson Cancer Center- Site Number : 8400005 — Houston, Texas
- Fred Hutchinson Cancer Center- Site Number : 8400010 — Seattle, Washington
- Servicios Médicos URUMED SpA_Investigational Site Number : 1520002 — Rancagua, General Bernardo O'Higgins
- BIOCINETIC Ltda_Investigational Site Number : 1520008 — Santiago, Reg Metropolitana de Santiago
- Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004 — Santiago, Reg Metropolitana de Santiago
- Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805_Investigational Site Number : 1520007 — Providencia,
- Hadassah Medical Center - PPDS_Investigational Site Number : 3760005 — Jerusalem, Jerusalem
- Sheba Medical Center - PPDS_Investigational Site Number : 3760003 — Ramat Gan,
- Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001 — Tel Aviv,
- Shamir Medical Center_Investigational Site Number : 3760004 — Tzrifin,
- Investigational Site Number : 3920001 — Kashiwa, Chiba
- Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001 — Amsterdam, North Holland
- Erasmus MC_Investigational Site Number : 5280003 — Rotterdam, South Holland
- Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007 — Barcelona, Barcelona [Barcelona]
- START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005 — Madrid,
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: contact-us@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.