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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sensei Biotherapeutics, Inc.
Study ID
NCT05864144
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SNS-101 (anti-VISTA) — DRUG
    SNS-101 IV every 21 days.
  • Cemiplimab — DRUG
    Cemiplimab IV every 21 days.

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
98 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Adverse Events - Part A & B [ Time Frame: Day 1 through 90 days after the last dose ]

Locations (10)

FacilityCityStateZIPSite coordinators
UCLA Hematology/OncologyLos AngelesCalifornia90095-
University of Colorado Cancer Center - Anschutz MedicalAuroraColorado80045-
Norton HealthcareLouisvilleKentucky40202-
Henry Ford CancerDetroitMichigan48202-
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029-
University of Pennsylvania, Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
Sanford Cancer CenterSioux FallsSouth Dakota57104-
NEXT Oncology DallasIrvingTexas75039-
South Texas Accelerated Research Therapeutics (START) San AntonioSan AntonioTexas78229-
START Mountain RegionWest Valley CityUtah84119-

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