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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
SNS-101 IV every 21 days.
Cemiplimab IV every 21 days.
UCLA Hematology/Oncology
Los Angeles, California, United States
University of Colorado Cancer Center - Anschutz Medical
Aurora, Colorado, United States
Norton Healthcare
Louisville, Kentucky, United States
Henry Ford Cancer
Detroit, Michigan, 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
Adverse Events - Part A & B
Incidence, nature and severity of treatment-related adverse events
Time frame: Day 1 through 90 days after the last dose
Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B
Incidence and nature of dose-limiting toxicities
Time frame: Approximately 15 months
Objective Response Rate (ORR) - Part C
Measured by RECIST 1.1 and iRECIST
Time frame: Day 1 through study completion (approximately 1 year)
Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C
Measured by maximum concentration
Time frame: Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C
Measured by area under the curve
Time frame: Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (total clearance) of SNS-101 - Part A, B & C
Measured by total clearance
Time frame: Day 1 through 30 days after the last dose
Determine pharmacokinetic profile (terminal half life) of SNS-101 - Part A, B & C
Measured by serum terminal half-life
Time frame: Day 1 through 30 days after the last dose
Number of participants with anti-SNS-101 antibodies post-administration of SNS-101 - Part A, B & C
Measured by anti-SNS-101 neutralizing anti-drug antibodies
Time frame: Day 1 through 30 days after the last dose
Objective Response Rate (ORR) - Part A & B
Measured by RECIST 1.1 and iRECIST
Time frame: Day 1 through study completion (approximately 1 year)
Duration of Response (DoR) - Part A, B & C
Measured by RECIST 1.1 and iRECIST
Time frame: Day 1 through study completion (approximately 1 year)
Disease Control Rate (DCR) - Part A, B & C
Measured by RECIST 1.1 and iRECIST
Time frame: Day 1 through study completion (approximately 1 year)
Progression Free Survival - Part A, B and C
Measured by RECIST 1.1 and iRECIST
Time frame: Day 1 through study completion - approximately 1 year (Part A, B & C)
Adverse Events - Part C
Incidence, nature and severity of treatment-related adverse events
Time frame: Day 1 through study completion (approximately 1 year)
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