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

Breast Cancer Clinical Trial

Official title:
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 Patients With Advanced Solid Tumors

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Cancer
  • Advanced Solid Tumor
  • Bladder Cancer
  • Breast Cancer
  • Cervix Cancer
  • Colon Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Kidney Neoplasms
  • Melanoma
  • Metastatic Cancer
  • Neoplasms
  • Non Small Cell Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Refractory Cancer
  • Sarcoma
  • Solid Tumor, Adult
  • Thyroid Cancer
  • Uterine Cancer
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
Clinical Trial Details
NCT number NCT05864144
Study type Interventional
Source Sensei Biotherapeutics, Inc.
Contact Janine McDermott
Phone 781-392-5556
Email jmcdermott@senseibio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 31, 2023
Completion date June 2027
View Details
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