Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

Study of Investigational Medication for Advanced Solid Tumors

Not Recruiting
18 years or above
All
Phase 1/2
33 participants needed

Study Overview

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Study Details

Treatment Period: enrolled participants will receive continuous treatment until disease progression (PD), unacceptable adverse event (AE), or other permanent discontinuation criteria.

The End of Treatment visit will occur 30 days ±7 days from last IMP administration or prior to initiation of further therapy, whichever occurs first.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neoplasm
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Cancer diagnosis for participants for Part 1A and Part 1B:

    1. Metastatic and/or unresectable HCC diagnosed by histology and/or cytology, or diagnosed clinically by the American Association for the Study of Liver Diseases (AASLD) criteria for participants with liver cirrhosis (participants without liver cirrhosis must be diagnosed histologically) OR Other histology/cytology proven advanced and/or metastatic non-HCC solid tumors
    2. Not amenable to available standard of care: participants must have experienced disease progression on/after standard of care, or no acceptable standard curative or palliative treatments exist (or are no longer effective), according to Investigator judgement, or the participant declines standard of care therapy.

  • Cancer diagnosis for participants for Part 2A:

    1. Metastatic NSCLC with no actionable driver gene mutants (such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK)), diagnosed by histology and/or cytology not amenable to available standard of care and must have progressed on/after therapy that included an anti-PD(L)-1 agent with or without platinum-based chemotherapy.
    2. Progressive disease should be observed during the course of anti-PD(L)-1 therapy or within 12 weeks from the last dose of anti-PD(L)-1 therapy
  • Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria

  • For all participants:

    1. Positive GPC3 expression on tumor tissue as determined locally or centrally
    2. Capable of giving signed informed consent

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
  • Predicted life expectancy ≤3 months.
  • For participants with HCC: Child Pugh Class B or C liver score within 14 days of initiation of IMP. Participants with Child Pugh Class B-7 score are allowed for Part 1A.
  • Known active brain metastases or leptomeningeal metastases.
  • History of allogenic or solid organ transplant
  • 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
  • Significant cardiovascular disease within 3 months prior to initiation of IMP, uncontrolled arrhythmia requiring medication, or unstable angina.
  • Ongoing AEs caused by any prior anti-cancer therapy >Grade 2
  • Known uncontrolled human immunodeficiency virus (HIV), hepatitis B infection, or known untreated current hepatitis C infection
  • Known second malignancy either progressing or requiring active treatment within the last year.
  • For combination therapy: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
  • Receipt of a live-virus vaccination within 28 days of planned treatment start.
  • For Part 2A, has received prior GPC3 targeted anticancer treatment.
  • Current pneumonitis or interstitial lung disease, or history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

This study investigates the safety, pharmacokinetics (PK), pharmacodynamics (PDy), and efficacy of an investigational medication, SAR444200, in adult participants with advanced solid tumors. The study is open-label, meaning both the researchers and participants know what treatment is being administered. Participants must be at least 18 years old and have previously treated metastatic malignancies, which are cancers that have spread to other parts of the body.

Participants in the study will receive SAR444200 as a monotherapy or in combination with other anti-cancer agents. The treatment will continue until the disease progresses, unacceptable adverse events occur, or other criteria for stopping treatment are met. The end of treatment visit will take place approximately 30 days after the last dose or before starting any new therapy.

  • Who can participate: Adults aged 18 and older with certain advanced solid tumors, including metastatic or unresectable liver cancer or non-small cell lung cancer, may be eligible. Participants must have progressed after standard treatments and have a positive GPC3 expression on tumor tissue.
  • Study details: Participants will be treated with the investigational medication SAR444200, either alone or with other anti-cancer agents. They will continue treatment until certain criteria are met, such as disease progression or adverse events.
Updated on 13 Jan 2026. Study ID: NCT05450562