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.
Checked against the public recordLast updated Aug 15, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Sensei Biotherapeutics, Inc.
- Interventions being studied
- Drug: SNS-101 (anti-VISTA); Drug: Cemiplimab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor. * Having received and failed or was intolerant to standard of care for advanced disease or not eligible for standard of care therapy with the following tumor types for patients in Phase 1 dose expansion cohorts: 1. Microsatellite Stable (MSS) CRC (both monotherapy and combination cohorts); no more than 3 lines of prior systemic therapy for metastatic disease. 2. H\&N cancer (combination cohort only); no more than 2 lines of prior systemic therapy for metastatic disease. 3. Melanoma (combination cohort only); no more than 3 lines of prior systemic therapy for metastatic disease, including at least 1 prior treatment with a BRAF inhibitor for patients with a BRAF mutation. 4. NSCLC (combination cohort only); no more than 2 lines of prior systemic therapy for metastatic disease, including at least 1 prior treatment with a targeted therapy for patients with a mutation such as EGFR, ALK, KRAS, or RET. 5. Patients with H\&N cancer, melanoma, and NSCLC (or additional tumor types that typically respond to PD1/PD-L1 monotherapy) must have received a prior PD1/PD-L1 where best response was stable disease and progression occurred during treatment or within 3 months of last dose of PD1/PD-L1. Additional tumor types and doses may be considered. * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Hematology/OncologyLos Angeles, California
- University of Colorado Cancer Center - Anschutz MedicalAurora, Colorado
- Norton HealthcareLouisville, Kentucky
- Henry Ford CancerDetroit, Michigan
- Icahn School of Medicine at Mt. SinaiNew York, New York
- University of Pennsylvania, Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania
- Sanford Cancer CenterSioux Falls, South Dakota
- NEXT Oncology DallasIrving, Texas
- South Texas Accelerated Research Therapeutics (START) San AntonioSan Antonio, Texas
- START Mountain RegionWest Valley City, Utah
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 15, 2025. Always confirm current availability with the study team.