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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05864144
Recruitment Status : Recruiting
First Posted : May 18, 2023
Last Update Posted : May 25, 2023
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sensei Biotherapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: SNS-101 (anti-VISTA) Drug: Cemiplimab Phase 1 Phase 2

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 (SNS-101 alone)
  • Part B: Phase 1 Combination Dose Escalation (SNS-101 in combination with cemiplimab)
  • Part C: Phase 2 Expansion Cohorts (SNS-101 alone or in combination with cemiplimab)
Study Design
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Study Type : Interventional
Estimated Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A - SNS-101 Monotherapy
SNS-101 IV alone every 21 days. Patients will 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
SNS-101 IV and cemiplimab IV every 21 days. Patients will 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 - Expansion Cohorts - 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically or cytologically documented locally advanced, unresectable or metastatic solid tumor.
  • Refractory or intolerant to standard of care for advanced disease or not eligible for standard of care therapy.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05864144


Contacts
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Contact: Joelle Lufkin 240-243-8000 jlufkin@senseibio.com

Locations
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United States, Texas
NEXT Oncology Dallas Recruiting
Irving, Texas, United States, 75039
Contact: Erica Torres    737-610-5180    etorres@nextoncology.com   
South Texas Accelerated Research Therapeutics (START) San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN, MSN    210-593-5265    isabel.jimenez@startsa.com   
United States, Utah
START Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Marie Asay    801-907-4770    marie.asay@startthecure.com   
Sponsors and Collaborators
Sensei Biotherapeutics, Inc.
Regeneron Pharmaceuticals
Investigators
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Study Director: Ron Weitzman, MD Sensei Biotherapeutics, Inc.
More Information
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Responsible Party: Sensei Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05864144    
Other Study ID Numbers: SNS-101-2-1
First Posted: May 18, 2023    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Kidney Neoplasms
Uterine Neoplasms
Uterine Cervical Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Urologic Neoplasms
Urologic Diseases
Kidney Diseases
Uterine Diseases
Uterine Cervical Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents