Study on the Safety and Effects of NTS071 in Patients with Advanced Solid Tumors with a Specific TP53 Mutation

Sponsor: Nutshell Therapeutics (Shanghai) Co., LTD.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07060989

Provider View

This clinical trial is testing a new drug, NTS071, to see if it is safe and effective for adults with advanced solid tumors that have a specific genetic mutation called TP53 Y220C.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, how well patients tolerate it, and the initial effectiveness of a new drug called NTS071 in adults with advanced solid tumors that have a TP53 Y220C mutation. The study is divided into two parts: Phase 1, which focuses on finding the right dose, and Phase 2a, which looks at how well the drug works in a larger group of patients.

Description

This is a first-in-human study, meaning it's the first time NTS071 is being tested in people. The study is open-label, so both the researchers and participants know what treatment is being given. It takes place at multiple centers and is designed to explore the safety, tolerability, and initial effectiveness of NTS071 in patients with advanced solid tumors that cannot be surgically removed and have a specific TP53 Y220C mutation.

The study has two main parts:

  • Phase 1: This part involves gradually increasing the dose of NTS071 to find the safest and most effective dose.
  • Phase 2a: This part expands the study to include more patients to better understand how well the drug works.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have advanced solid tumors with a TP53 Y220C mutation.
  • Have received one or more previous cancer treatments and the disease has progressed.
  • Have at least one tumor that can be measured by scans.
  • 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 adequate organ and bone marrow function as determined by specific medical tests.

Exclusion Criteria

  • Have a primary brain tumor or untreated cancer that has spread to the brain.
  • Have had another type of cancer diagnosed or treated within the past two years.
  • Have not recovered from side effects of previous treatments to a mild level or back to baseline.
  • Have significant heart disease, such as heart failure.
  • Have active hepatitis B, hepatitis C, or HIV infection.
  • Have a psychiatric or substance abuse disorder that would interfere with participating in the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.