A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

August 31, 2026 updated by: Sensei Biotherapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The Phase 1 portion is conducted in two parts; A and B: Phase 2 is planned in Part C.

  • Part A: Phase 1 Monotherapy Dose Escalation and Dose Expansion (SNS-101 alone)
  • Part B: Phase 1 Combination Dose Escalation and Dose Expansion (SNS-101 in combination with cemiplimab)

Once the dose escalation portion was complete, enrollment expanded to targeted tumor types:

  • Approximately 10 patients with colorectal cancer (CRC) will be enrolled in the Monotherapy Dose Expansion.

    o Additional tumor types and doses may be considered upon consultation with the Sponsor.

  • Approximately 50 patients with CRC, head and neck cancer (H&N), melanoma, and non-small cell lung cancer (NSCLC) will be enrolled in the Combination Dose Expansion.

    • A minimum of 8 and a maximum of 10 CRC patients will be enrolled in the Combination Dose Expansion.
    • Additional tumor types and doses may be considered upon consultation with the Sponsor.

The Phase 2, Part C Cohort Expansion will further evaluate efficacy at the selected dose(s.).

Following completion of the Phase 1 portions of the study, the sponsor decided not to initiate the Phase 2 portion. No participants were enrolled in the planned Phase 2 Part C.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center - Anschutz Medical
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Cancer
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt. Sinai
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Perelman Center for Advanced Medicine
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center
    • Texas
      • Irving, Texas, United States, 75039
        • NEXT Oncology Dallas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics (START) San Antonio
    • Utah
      • West Valley City, Utah, United States, 84119
        • START Mountain Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion
SNS-101 IV alone every 21 days. Patients initially enroll in dose escalation cohorts.
Drug: SNS-101 (anti-VISTA)
SNS-101 IV every 21 days.
Experimental: Part B - SNS-101 in combination with cemiplimab and Dose Expansion
SNS-101 IV and cemiplimab IV every 21 days. Patients initially enroll in dose escalation cohorts.
Drug: SNS-101 (anti-VISTA)
SNS-101 IV every 21 days.
Drug: Cemiplimab
Cemiplimab IV every 21 days.
Experimental: Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab

SNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.

Following completion of the Phase 1 Parts A and B portions of the study, the Phase 2, Part C portion was never initiated. No participants were enrolled in Part C.
Drug: SNS-101 (anti-VISTA)
SNS-101 IV every 21 days.
Drug: Cemiplimab
Cemiplimab IV every 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events - Part A & B
Time Frame: Day 1 through 90 days after the last dose
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
Time Frame: Approximately 15 months
Incidence and nature of dose-limiting toxicities
Approximately 15 months
Objective Response Rate (ORR) - Part C. Part C was never initiated.
Time Frame: Day 1 through study completion (approximately 1 year).
Measured by RECIST 1.1 and iRECIST
Day 1 through study completion (approximately 1 year).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) - Part A & B
Time Frame: Day 1 through study completion (approximately 1 year)
Measured by RECIST 1.1 and iRECIST
Day 1 through study completion (approximately 1 year)
Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B.& C. Part C was never initiated.
Time Frame: Day 1 through 30 days after the last dose
Measured by maximum concentration
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C. Part C was never initiated.
Time Frame: Day 1 through 30 days after the last dose
Measured by area under the curve
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C. Part C was never initiated.
Time Frame: Day 1 through 30 days after the last dose
Measured by total clearance
Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C. Part C was never initiated.
Time Frame: Day 1 through 30 days after the last dose
Measured by serum terminal half-life
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. Part C was never initiated.
Time Frame: Day 1 through 30 days after the last dose
Measured by anti-SNS-101 neutralizing anti-drug antibodies
Day 1 through 30 days after the last dose
Duration of Response (DoR) - Part A, B & C. Part C was never initiated.
Time Frame: Day 1 through study completion (approximately 1 year)
Measured by RECIST 1.1 and iRECIST
Day 1 through study completion (approximately 1 year)
Disease Control Rate (DCR) - Part A, B & C. Part C was never initiated.
Time Frame: Day 1 through study completion (approximately 1 year)
Measured by RECIST 1.1 and iRECIST
Day 1 through study completion (approximately 1 year)
Progression Free Survival - Part A, B and C. Part C was never initiated.
Time Frame: Day 1 through study completion - approximately 1 year (Part A, B & C)
Measured by RECIST 1.1 and iRECIST
Day 1 through study completion - approximately 1 year (Part A, B & C)
Adverse Events - Part C. Part C was never innitiated.
Time Frame: Day 1 through study completion (approximately 1 year)
Incidence, nature and severity of treatment-related adverse events
Day 1 through study completion (approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensei Biotherapeutics, Inc.

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Ron Weitzman, MD, Sensei Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Actual)

June 2, 2026

Study Completion (Actual)

June 2, 2026

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNS-101-2-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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