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.
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
- Are there results?
- None posted in the registry
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.
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
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Sensei Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ron Weitzman, MD, Study director, Sensei Biotherapeutics, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05864144
- Acronym / sponsor ID
- SNS-101-2-1
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumor, Head and Neck Cancer, Breast Cancer, Colon Cancer, Pancreatic Cancer
- Keywords
- Solnerstotug
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sensei Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 31 May 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion | Experimental | Drug: SNS-101 (anti-VISTA)SNS-101 IV alone every 21 days. Patients initially enroll in dose escalation cohorts. |
| Part B - SNS-101 in combination with cemiplimab and Dose Expansion | Experimental | Drug: SNS-101 (anti-VISTA), Drug: CemiplimabSNS-101 IV and cemiplimab IV every 21 days. Patients initially enroll in dose escalation cohorts. |
| Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab | Experimental | Drug: SNS-101 (anti-VISTA), Drug: CemiplimabSNS-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Additional tumor types and doses may be considered.
- Measurable disease
- ECOG performance status 0 or 1.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNS-101 (anti-VISTA)SNS-101 IV every 21 days. | Drug | Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion, Part B - SNS-101 in combination with cemiplimab and Dose Expansion, Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab |
| CemiplimabCemiplimab IV every 21 days. | Drug | Part B - SNS-101 in combination with cemiplimab and Dose Expansion, Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab |
Primary outcome
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
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
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
10 secondary outcomes
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
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
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
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
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
Objective Response Rate (ORR) - Part A & B
Time frame: Day 1 through study completion (approximately 1 year)
Duration of Response (DoR) - Part A, B & C. Part C was never initiated.
Time frame: 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)
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)
Adverse Events - Part C. Part C was never innitiated.
Time frame: Day 1 through study completion (approximately 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Weitzman, MD study director
Sensei Biotherapeutics, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events - Part A & B (time frame: Day 1 through 90 days after the last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.