First-in-Human Study of TST003 for Patients with Solid Tumors

Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05731271

Provider View

This clinical trial is testing a new drug, TST003, to see if it is safe for patients with solid tumors. The study will determine the best dose, how long the drug stays in the body, its side effects, and if it helps treat cancer. Participants will receive the drug through a vein every three weeks and will have regular check-ups to monitor their health.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of a new drug called TST003 in patients with cancer. The study aims to find out the safest dose, how long the drug remains in the body, what side effects it may cause, and whether it helps treat cancer. Participants will receive TST003 through an IV every three weeks. Before starting the treatment, participants may need to visit the study site 2-4 times for tests to confirm eligibility. After starting the drug, participants will return for regular check-ups to monitor their health and the drug's effects. Participants will continue the treatment as long as they benefit from it. Additional tests will be required at the end of the study.

Description

This study is divided into two parts. In Part 1, patients with any type of advanced solid tumor will receive increasing doses of TST003 every three weeks to find the safest dose. Between 18 and 39 patients will participate in this part. In Part 2, the study will focus on patients with advanced colorectal cancer, with about 26-36 patients in each group. The entire study will last about three years and will include various tests like blood tests, heart tests, and scans to monitor the drug's effects and safety.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must agree to participate and follow the study rules.
  • For Part 1: Must have advanced solid tumors that cannot be removed by surgery. For Part 2: Must have advanced colorectal cancer.
  • Cancer must have worsened after previous treatments, with no other standard treatment options available.
  • Must have at least one tumor that can be measured (Part 2 only).
  • Must be in good general health with a performance status of 0 or 1.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate kidney, bone marrow, and liver function based on specific blood tests.
  • Women and men of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose.

Exclusion Criteria

  • Have untreated or symptomatic brain metastases.
  • Have received certain cancer treatments within 4 weeks before starting the study drug.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of certain lung diseases or severe heart conditions.
  • Have uncontrolled high blood pressure.
  • Have severe intestinal diseases or active infections.
  • Have active hepatitis or HIV infection.
  • Are pregnant or breastfeeding.
  • Have allergies to the study drug or similar drugs.
  • Are currently participating in another clinical trial.
  • Have any severe medical conditions that could interfere with the study.

Additional Exclusion Criteria for Part 2:

  • Have received a specific type of targeted therapy before.
  • Have had another cancer within the last 3 years, except for certain localized cancers that have been treated and cured.
  • Cannot undergo a required tumor biopsy during the study.

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