Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors
Brief description of study
This is a single group, treatment, Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety 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.
Detailed description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Neoplasm
Age: 18 Years
Gender: Male or Female
- 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 patient declines standard of care therapy.
- Cancer diagnosis for participants for Part 2A: Metastatic NSCLC diagnosed by histology
and/or cytology not amenable to available standard of care
- Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria
- For all participants:
- Positive GPC3 expression on tumor tissue as determined locally or centrally
- Capable of giving signed informed consent
- 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 patient's potential participation in a clinical trial.
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