Study on SNS-101 Alone and with Cemiplimab for Advanced Solid Tumors

Sponsor: Sensei Biotherapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05864144

Provider View

This clinical trial is testing a new treatment called SNS-101, both by itself and combined with another drug, cemiplimab, to see if it is safe and effective for patients with advanced solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug, SNS-101, which targets a protein called VISTA. It will be tested alone and in combination with cemiplimab in patients with advanced solid tumors. The study is divided into three parts, focusing on different doses and combinations to find the most effective treatment.

Description

This clinical trial is the first time SNS-101 is being tested in humans. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study is conducted in multiple centers and has three parts:

  • Part A: Tests different doses of SNS-101 alone to find the safest and most effective dose.
  • Part B: Tests different doses of SNS-101 combined with cemiplimab to find the safest and most effective combination.
  • Part C: Expands the study to include more patients with specific types of cancer to further evaluate the treatment's effectiveness.

The study will include patients with colorectal cancer, head and neck cancer, melanoma, and non-small cell lung cancer. The goal is to determine if SNS-101, alone or with cemiplimab, can help control these cancers.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced solid tumor that cannot be removed by surgery.
  • Have tried standard treatments for advanced disease, but they did not work or were not tolerated.
  • Have specific types of cancer, such as colorectal cancer, head and neck cancer, melanoma, or non-small cell lung cancer, and meet certain treatment history requirements.
  • Have measurable disease that can be tracked.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Be willing to provide tumor samples before and during treatment.
  • Have adequate organ function as determined by specific tests.
  • Agree to use effective contraception during the study and for 180 days after, and not donate eggs or sperm during the study.

Exclusion Criteria

  • Have used certain cancer treatments within 2 weeks before starting the study.
  • Have unresolved side effects from previous cancer treatments.
  • Have had severe immune-related side effects from previous treatments targeting PD-1/PD-L1 or similar therapies.
  • Have another cancer that required treatment within the last 2 years, except for certain non-threatening cancers.
  • Have known brain metastasis or cancer spread to the membranes around the brain and spinal cord.
  • Have a history of severe allergic reactions to similar drugs.
  • Be pregnant or breastfeeding.

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