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

NCT ID: NCT05864144

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2027-06-30

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.

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SNS-101 (anti-VISTA)

Intervention Type: DRUG

SNS-101 IV every 21 days.

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.

Group Type: EXPERIMENTAL

SNS-101 (anti-VISTA)

Intervention Type: DRUG

SNS-101 IV every 21 days.

Cemiplimab

Intervention Type: DRUG

Cemiplimab IV every 21 days.

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.

Group Type: EXPERIMENTAL

SNS-101 (anti-VISTA)

Intervention Type: DRUG

SNS-101 IV every 21 days.

Cemiplimab

Intervention Type: DRUG

Cemiplimab IV every 21 days.

Interventions

SNS-101 (anti-VISTA)

SNS-101 IV every 21 days.

Intervention Type: DRUG

Cemiplimab

Cemiplimab IV every 21 days.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sensei Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Weitzman, MD

Role: STUDY_DIRECTOR

Sensei Biotherapeutics, Inc.

Locations

Henry Ford Cancer

Detroit, Michigan, United States

University of Colorado Cancer Center - Anschutz Medical

Aurora, Colorado, United States

Norton Healthcare

Louisville, Kentucky, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

University of Pennsylvania, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

NEXT Oncology Dallas

Irving, Texas, United States

South Texas Accelerated Research Therapeutics (START) San Antonio

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Countries

United States

Other Identifiers

SNS-101-2-1

Identifier Type: -

Identifier Source: org_study_id