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 Patient

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.

Protocol#: SENSEIBIO-SNS-101-2-1