A Study Of SNS-101 (Anti VISTA) Monotherapy And In Combination With Cemiplimab In Patients With Advanced Solid Tumors

Study Overview

A Study of SNS-101 (Anti VISTA) 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.

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. This study is being conducted in three parts: * 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) * Part C: Phase 2 Cohort Expansion (SNS-101 alone or in combination with cemiplimab) Once the dose escalation portion is complete enrollment will expand 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.

Solid Tumor, Adult
Advanced Solid Tumor
Head and Neck Cancer
Breast Cancer
Colon Cancer
Pancreatic Cancer
Gastric Cancer
Esophageal Cancer
Prostate Cancer
Uterine Cancer
Cervix Cancer
Ovarian Cancer
Kidney Cancer
Bladder Cancer
Thyroid Cancer
Melanoma
Sarcoma
Advanced Cancer
Metastatic Cancer
Refractory Cancer
Non Small Cell Lung Cancer
Merkel Cell Carcinoma

DRUG: SNS-101 (anti-VISTA)
DRUG: Cemiplimab

SNS-101-2-1

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-04-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-11
First Submitted that Met QC Criteria 2023-05-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-12
First Posted (ACTUAL) 2023-05-18	Results First Posted N/A	Last Verified 2024-12

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

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 will 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 will 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.	DRUG: SNS-101 (anti-VISTA) SNS-101 IV every 21 days. DRUG: Cemiplimab Cemiplimab IV every 21 days.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion

SNS-101 IV alone every 21 days. Patients will 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 will 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.

DRUG: SNS-101 (anti-VISTA)

SNS-101 IV every 21 days.

DRUG: Cemiplimab

Cemiplimab IV every 21 days.

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C	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	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	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	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	Measured by anti-SNS-101 neutralizing anti-drug antibodies	Day 1 through 30 days after the last dose
Objective Response Rate (ORR) - Part A & B	Measured by RECIST 1.1 and iRECIST	Day 1 through study completion (approximately 1 year)
Duration of Response (DoR) - Part A, B & C	Measured by RECIST 1.1 and iRECIST	Day 1 through study completion (approximately 1 year)
Disease Control Rate (DCR) - Part A, B & C	Measured by RECIST 1.1 and iRECIST	Day 1 through study completion (approximately 1 year)
Progression Free Survival - Part A, B and C	Measured by RECIST 1.1 and iRECIST	Day 1 through study completion - approximately 1 year (Part A, B & C)
Adverse Events - Part C	Incidence, nature and severity of treatment-related adverse events	Day 1 through study completion (approximately 1 year)

Contacts and Locations

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

Study Contact

Name: Janine McDermott

Phone Number: 781-392-5556

Email: jmcdermott@senseibio.com

Study Contact Backup

Name: Joelle Lufkin

Phone Number:

Email: jlufkin@senseibio.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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.

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.

Collaborators and Investigators

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

Regeneron Pharmaceuticals

Investigators

STUDY_DIRECTOR: Ron Weitzman, MD, Sensei Biotherapeutics, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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