South Texas Accelerated Research Therapeutics | START Mountain Region
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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.
Full 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:
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.
Enrollment
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Inclusion and exclusion criteria
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:
Additional tumor types and doses may be considered.
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
169 participants in 3 patient groups
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Central trial contact
Joelle Lufkin; Janine McDermott
Data sourced from clinicaltrials.gov
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