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

Sponsor
Sensei Biotherapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05864144
Collaborator
Regeneron Pharmaceuticals (Industry)
129
Enrollment
3
Locations
3
Arms
48
Anticipated Duration (Months)
43
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2027
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

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

Primary Outcome Measures

  1. Adverse Events - Part A & B [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 [Approximately 15 months]

    Incidence and nature of dose-limiting toxicities

  3. Objective Response Rate (ORR) - Part C [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 [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 [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 [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 [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 [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 [Day 1 through study completion (approximately 1 year)]

    Measured by RECIST 1.1 and iRECIST

  7. Duration of Response (DoR) - Part A, B & C [Day 1 through study completion (approximately 1 year)]

    Measured by RECIST 1.1 and iRECIST

  8. Disease Control Rate (DCR) - Part A, B & C [Day 1 through study completion (approximately 1 year)]

    Measured by RECIST 1.1 and iRECIST

  9. Progression Free Survival - Part A, B and C [Day 1 through study completion - approximately 1 year (Part A, B & C)]

    Measured by RECIST 1.1 and iRECIST

  10. Adverse Events - Part C [Day 1 through study completion (approximately 1 year)]

    Incidence, nature and severity of treatment-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 NEXT Oncology Dallas Irving Texas United States 75039
2 South Texas Accelerated Research Therapeutics (START) San Antonio San Antonio Texas United States 78229
3 START Mountain Region West Valley City Utah United States 84119

Sponsors and Collaborators

  • Sensei Biotherapeutics, Inc.
  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Ron Weitzman, MD, Sensei Biotherapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sensei Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05864144
Other Study ID Numbers:
  • SNS-101-2-1
First Posted:
May 18, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Kidney Neoplasms
Uterine Neoplasms
Uterine Cervical Neoplasms
Cemiplimab

Study Results

No Results Posted as of May 25, 2023