Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT05864144

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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2