A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT05584670

Run by

Sanofi

People needed

542

Starts

2022-11-29

Expected to finish

2028-06-28

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dose escalation Part 1A and Japan Cohort F
• Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant
• Dose escalation Part 1B
• Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and for who, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant.
• Dose escalation Part 1C
• Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer
• Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
• Dose expansion/optimization Part 2
• Cancer diagnosis:
• Participants in Cohorts A1 and A2 (Part 2A): Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
• Participants in Cohort B (part 2A): Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants (participants without cirrhosis must have had histological confirmation of diagnosis)
• Participants in Cohorts C1 and C2 (part 2A):
• Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \& 3 gastro esophageal junction (GEJ) adenocarcinoma
• Disease with any CPS scoring. No need for CPS determination at local laboratory
• Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.
• Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.
• Participants in Part 2A Cohorts E1 and E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer.
• Participants in Part 2A Cohorts E1, and E2 and Part 2B Cohort E3 MSI status:
• Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.
• Participants in Part 2A Cohorts E1, E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
• Part 2C Cohorts G1, G2 and G3: Participants with histologically confirmed unresectable locally advanced or metastatic melanoma
• Prior anticancer therapy (For dose expansion/optimization Part 2 only)
• Participants in Cohorts A1 and A2: Participants must have received at least 1 systemic therapy for the metastatic setting and must not be amenable to the available SOC.
• Participants in Cohort B: Participants who have received at least 1 prior anticancer therapy, including an anti-PD1/PD-L1 containing regimen, and for whom have progressed after a primary or secondary resistance to an anti-PD1/PD-L1.
• Participants in Cohorts C1 and C2: Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care.

You may not qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
• Predicted life expectancy ≤3 months
• For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.
• Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment
• Known active brain metastases or leptomeningeal metastases
• History of treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity or have not resolved to Grade ≤1
• Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine
• Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration
• Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
• Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.
• Organ transplant requiring immunosuppressive treatment
• Uncontrolled or active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency
• NOTE: Other Inclusion/Exclusion criteria may apply.
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where it is running

• START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005 — Madrid, Spain (enrolling)
• University of Iowa- Site Number : 8400014 — Iowa City, Iowa, United States (enrolling)
• The University of Kansas Cancer Center - Westwood- Site Number : 8400008 — Westwood, Kansas, United States (enrolling)
• Karmanos Cancer Institute - Detroit- Site Number : 8400006 — Detroit, Michigan, United States (enrolling)
• John Theurer Cancer Center- Site Number : 8400001 — Hackensack, New Jersey, United States (enrolling)
• NYU Langone Medical Center- Site Number : 8400013 — New York, New York, United States (enrolling)
• Rhode Island Hospital - Providence - Eddy Street- Site Number : 8400004 — Providence, Rhode Island, United States (enrolling)
• The University of Texas MD Anderson Cancer Center- Site Number : 8400005 — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center- Site Number : 8400010 — Seattle, Washington, United States (enrolling)
• Servicios Médicos URUMED SpA_Investigational Site Number : 1520002 — Rancagua, General Bernardo O'Higgins, Chile (enrolling)
• BIOCINETIC Ltda_Investigational Site Number : 1520008 — Santiago, Reg Metropolitana de Santiago, Chile (enrolling)
• Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004 — Santiago, Reg Metropolitana de Santiago, Chile (enrolling)
• Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805_Investigational Site Number : 1520007 — Providencia, Chile (enrolling)
• Hadassah Medical Center - PPDS_Investigational Site Number : 3760005 — Jerusalem, Jerusalem, Israel (enrolling)
• Sheba Medical Center - PPDS_Investigational Site Number : 3760003 — Ramat Gan, Israel (enrolling)
• Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001 — Tel Aviv, Israel (enrolling)
• Shamir Medical Center_Investigational Site Number : 3760004 — Tzrifin, Israel (enrolling)
• Christiana Care Health System - Newark- Site Number : 8400011 — Newark, Delaware, United States (enrolling)
• Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001 — Amsterdam, North Holland, Netherlands (enrolling)
• Erasmus MC_Investigational Site Number : 5280003 — Rotterdam, South Holland, Netherlands (enrolling)
• Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007 — Barcelona, Barcelona [Barcelona], Spain (enrolling)
• Investigational Site Number : 3920001 — Kashiwa, Chiba, Japan

Full record on ClinicalTrials.gov

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