A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Solid Tumor, Adult, Advanced Solid Tumor, Head and Neck Cancer
About this trial
This is an interventional treatment trial for Solid Tumor, Adult
Eligibility Criteria
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. Measurable disease. 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.
Sites / Locations
- NEXT Oncology DallasRecruiting
- South Texas Accelerated Research Therapeutics (START) San AntonioRecruiting
- START Mountain RegionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part A - SNS-101 Monotherapy
Part B - SNS-101 in combination with cemiplimab
Part C - Expansion Cohorts - SNS-101 alone or in combination with cemiplimab
SNS-101 IV alone every 21 days. Patients will enroll in dose escalation cohorts.
SNS-101 IV and cemiplimab IV every 21 days. Patients will enroll in dose escalation cohorts.
SNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.