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Active, Not Recruiting

NCT Number: NCT05864144

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Solid Tumor, Adult Adenocarcinoma Adnexal Diseases Advanced Cancer Advanced Solid Tumor Bladder Cancer Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Cervix Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Merkel Cell Carcinoma Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non Small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Polyomavirus Infections Prostate Cancer Prostatic Diseases Prostatic Neoplasms Refractory Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Tumor Virus Infections Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCLA Hematology/Oncology, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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.

Treatment and study plan

SNS-101 (anti-VISTA)

Drug

SNS-101 IV every 21 days.

cemiplimab

Drug

Cemiplimab IV every 21 days.

Primary outcomes

  1. 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

  2. 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

  3. Objective Response Rate (ORR) - Part C

    Time frame: Day 1 through study completion (approximately 1 year)

    Measured by RECIST 1.1 and iRECIST

Secondary outcomes

  1. Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C

    Time frame: Day 1 through 30 days after the last dose

    Measured by maximum concentration

  2. Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C

    Time frame: Day 1 through 30 days after the last dose

    Measured by area under the curve

  3. Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C

    Time frame: Day 1 through 30 days after the last dose

    Measured by total clearance

  4. Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C

    Time frame: Day 1 through 30 days after the last dose

    Measured by serum terminal half-life

  5. Number of participants with anti-SNS-101 antibodies post-administration of SNS-101 - Part A, B & C

    Time frame: Day 1 through 30 days after the last dose

    Measured by anti-SNS-101 neutralizing anti-drug antibodies

  6. Objective Response Rate (ORR) - Part A & B

    Time frame: Day 1 through study completion (approximately 1 year)

    Measured by RECIST 1.1 and iRECIST

  7. Duration of Response (DoR) - Part A, B & C

    Time frame: Day 1 through study completion (approximately 1 year)

    Measured by RECIST 1.1 and iRECIST

  8. Disease Control Rate (DCR) - Part A, B & C

    Time frame: Day 1 through study completion (approximately 1 year)

    Measured by RECIST 1.1 and iRECIST

  9. Progression Free Survival - Part A, B and C

    Time frame: Day 1 through study completion - approximately 1 year (Part A, B & C)

    Measured by RECIST 1.1 and iRECIST

  10. Adverse Events - Part C

    Time frame: Day 1 through study completion (approximately 1 year)

    Incidence, nature and severity of treatment-related adverse events

Sponsors and collaborators

Lead sponsor

Sensei Biotherapeutics, Inc.

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 18, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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