A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With 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
1 other identifier
interventional
98
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2023
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 15, 2025
August 1, 2025
4 years
April 21, 2023
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse Events - Part A & B
Incidence, nature and severity of treatment-related adverse events
Day 1 through 90 days after the last dose
Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B
Incidence and nature of dose-limiting toxicities
Approximately 15 months
Objective Response Rate (ORR) - Part C
Measured by RECIST 1.1 and iRECIST
Day 1 through study completion (approximately 1 year)
Secondary Outcomes (10)
Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C
Day 1 through 30 days after the last dose
Number of participants with anti-SNS-101 antibodies post-administration of SNS-101 - Part A, B & C
Day 1 through 30 days after the last dose
- +5 more secondary outcomes
Study Arms (3)
Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion
EXPERIMENTALSNS-101 IV alone every 21 days. Patients will initially enroll in dose escalation cohorts.
Part B - SNS-101 in combination with cemiplimab and Dose Expansion
EXPERIMENTALSNS-101 IV and cemiplimab IV every 21 days. Patients will initially enroll in dose escalation cohorts.
Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab
EXPERIMENTALSNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.
Interventions
SNS-101 IV every 21 days.
Cemiplimab IV every 21 days.
Eligibility Criteria
You may qualify if:
- 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:
- Microsatellite Stable (MSS) CRC (both monotherapy and combination cohorts); no more than 3 lines of prior systemic therapy for metastatic disease.
- H\&N cancer (combination cohort only); no more than 2 lines of prior systemic therapy for metastatic disease.
- 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.
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sensei Biotherapeutics, Inc.lead
- Regeneron Pharmaceuticalscollaborator
Study Sites (10)
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
University of Colorado Cancer Center - Anschutz Medical
Aurora, Colorado, 80045, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
Henry Ford Cancer
Detroit, Michigan, 48202, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
NEXT Oncology Dallas
Irving, Texas, 75039, United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, 78229, United States
START Mountain Region
West Valley City, Utah, 84119, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ron Weitzman, MD
Sensei Biotherapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2023
First Posted
May 18, 2023
Study Start
May 31, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share