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 SAR444200-based Regimen in Participants With Advanced Solid Tumors.
Description
Brief 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.
Detailed 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.
Phase
N/AInclusion and Exclusion 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.
- 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:
- 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 participant's potential participation in a clinical trial.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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