Bladder Cancer Clinical Trial
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors.
This is a first-in-human, Phase 1/2 open-label, multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors.
This study is being conducted in three parts:
Part A: Phase 1 Monotherapy Dose Escalation (SNS-101 alone)
Part B: Phase 1 Combination Dose Escalation (SNS-101 in combination with cemiplimab)
Part C: Phase 2 Expansion Cohorts (SNS-101 alone or in combination with cemiplimab)
Key Inclusion Criteria:
Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor.
Refractory or intolerant to standard of care for advanced disease or not eligible for standard of care therapy.
ECOG performance status 0 or 1.
Life expectancy of ≥ 3 months.
Willing to provide pre-treatment (archival or fresh) and on-treatment tumor biopsy samples.
Adequate organ function
Women of childbearing potential and fertile males with WOCBP partners must use highly effective contraception during the study and for 180 days after the study. Patients must agree not to donate eggs (ova, oocytes) or sperm during the study.
Key Exclusion Criteria:
Use of anti-PD-1/PD-L1 targeting monoclonal antibody therapy, monoclonal antibody therapy, chemotherapy, biologic, investigational, or radiotherapy within 2 weeks of Cycle 1 Day 1.
Clinically significant unresolved toxicities from prior anticancer therapy.
Grade 3 or higher immune-related adverse event on prior PD-1/PD-L1 blockade or prior agents targeting stimulatory or co-inhibitory T cell receptor.
Known other previous/current malignancy requiring treatment within ≤ 2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma.
Known asymptomatic or symptomatic brain metastasis or leptomeningeal disease.
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
Women who are pregnant or breastfeeding.
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There are 3 Locations for this study
Irving Texas, 75039, United States More Info
San Antonio Texas, 78229, United States More Info
West Valley City Utah, 84119, United States More Info
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