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

  • STATUS
    Recruiting
  • End date
    Dec 12, 2030
  • participants needed
    106
  • sponsor
    Sanofi
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Updated on 3 December 2024
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primary cancer
cancer diagnosis

Summary

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.

Description

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.

Details
Condition Neoplasm
Age 18years or above
Treatment Atezolizumab, Cemiplimab, SAR444200
Clinical Study IdentifierNCT05450562
SponsorSanofi
Last Modified on3 December 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Cancer diagnosis for participants for Part 1A and Part 1B
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
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
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
Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria
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
For all participants
Positive GPC3 expression on tumor tissue as determined locally or centrally
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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