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Evaluating SNS-101 and Cemiplimab for Advanced Solid Tumors

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Phase1; Phase2 Interventional Sensei Biotherapeutics, Inc. · NCT05864144

This study is testing a new treatment called SNS-101, both alone and with another drug, to see if it can help people with advanced solid tumors like colorectal cancer and melanoma.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment169 (estimated)
Ages18 Years and up
SexAll
SponsorSensei Biotherapeutics, Inc. Industry-sponsored
Drugs / interventionschemotherapy, cemiplimab
Locations11 sites (Los Angeles, California and 10 other locations)
Trial IDNCT05864144 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti-VISTA monoclonal antibody, both as a standalone treatment and in combination with cemiplimab for patients with advanced solid tumors. The study is structured in three parts: initial dose escalation and expansion for monotherapy, followed by combination therapy, and finally a cohort expansion targeting specific tumor types. Patients with colorectal cancer, head and neck cancer, melanoma, and non-small cell lung cancer will be enrolled based on their treatment history and eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors who have failed or are intolerant to standard therapies.

Not a fit: Patients with early-stage or resectable tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: While this approach is novel, similar studies targeting immune pathways have shown promise in treating advanced cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumor, AdultAdvanced Solid TumorHead and Neck CancerBreast CancerColon CancerPancreatic CancerGastric CancerEsophageal Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.