Solid Tumor, AdultPhase 1/2NCT05864144

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

A Phase 1/2 study testing SNS-101 (anti-VISTA) and Cemiplimab in people with Solid Tumor, Adult and Advanced Solid Tumor, run by Sensei Biotherapeutics, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Adult, Advanced Solid Tumor, Head and Neck Cancer
What is being tested?: SNS-101 (anti-VISTA) and Cemiplimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 10 sitesUnited States
Study dates: 31 May 2023to 2 Jun 2026
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

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

Other trials in United States

About this study

Official title: 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

Read the 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.
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.

Conditions: Solid Tumor, Adult, Advanced Solid Tumor, Head and Neck Cancer, Breast Cancer, Colon Cancer, Pancreatic Cancer
Being tested: SNS-101 (anti-VISTA), Cemiplimab
Keywords: Solnerstotug
Medical subject headings: Head and Neck Neoplasms, Breast Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Prostatic Neoplasms, Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SNS-101 (anti-VISTA)Drug
SNS-101 IV every 21 days.
CemiplimabDrug
Cemiplimab IV every 21 days.

Study groups in NCT05864144
Study group	Role	What they receive
Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion	Experimental	SNS-101 IV alone every 21 days. Patients initially enroll in dose escalation cohorts. Receives: Drug: SNS-101 (anti-VISTA)
Part B - SNS-101 in combination with cemiplimab and Dose Expansion	Experimental	SNS-101 IV and cemiplimab IV every 21 days. Patients initially enroll in dose escalation cohorts. Receives: Drug: SNS-101 (anti-VISTA); Drug: Cemiplimab
Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab	Experimental	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. Receives: Drug: SNS-101 (anti-VISTA); Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events - Part A & B
Incidence, nature and severity of treatment-related adverse events
Measured: 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
Measured: Approximately 15 months
Objective Response Rate (ORR) - Part C. Part C was never initiated.
Measured by RECIST 1.1 and iRECIST
Measured: Day 1 through study completion (approximately 1 year).

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 20232 Jun 2026

First posted18 May 2023
Study start31 May 2023
Primary completion2 Jun 2026
Study completion2 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05864144
Sponsor's protocol ID: SNS-101-2-1
Status last verified: Aug 2026
First submitted: 21 Apr 2023
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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