Spots Global Cancer Trial Database for A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

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.

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 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 MTD/RP2D is determined, enrollment will expand to targeted tumor types: * Up to 10 patients with colorectal cancer (CRC) will be enrolled in the Monotherapy Dose Expansion at the monotherapy MTD/RP2D. o Additional tumor types and doses may be considered upon consultation with the Sponsor. * Up to 30 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 at the combination MTD/RP2D. * 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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