Study on the Safety and Tolerability of TST001 for Advanced or Metastatic Solid Tumors

Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04396821

Provider View

This clinical trial is testing a new drug, TST001, alone or with other treatments, to see if it is safe and well-tolerated in adults with advanced or metastatic solid tumors, including stomach, gastroesophageal, and pancreatic cancers.

Patient Parameters

Program Overview

This study is exploring a new treatment called TST001, which is a type of antibody therapy. The trial is in its early stages and aims to find out if TST001 is safe and how well it works when used alone or with other treatments like nivolumab or standard chemotherapy. The study focuses on patients with advanced or metastatic solid tumors, including those affecting the stomach, gastroesophageal junction, and pancreas.

Description

The trial is divided into two parts:

Part A:

  • This part is about finding the right dose of TST001. Participants will be divided into two groups, receiving the drug every 2 or 3 weeks. Between 18 and 36 people will take part.

Part B:

  • Cohort A: For patients with advanced stomach or gastroesophageal cancer who haven't had treatment before. They will receive TST001 with nivolumab and a chemotherapy regimen called mFOLFOX6. The study will test two doses of TST001, and about 12-42 patients will be involved.
  • Cohort B: For patients with stomach or gastroesophageal cancer that has worsened after previous treatments. They will receive TST001 with nivolumab. The study will start with a small group to ensure safety, then expand to include more patients with a specific tumor marker.
  • Cohort C: For patients with advanced pancreatic cancer who haven't had treatment before. They will receive TST001 with gemcitabine and albumin-bound paclitaxel. The study will test two doses of TST001, and about 12-42 patients will be involved.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have a confirmed diagnosis of advanced or metastatic solid tumors.

Part A only:

  • Have tried standard treatments without success, cannot tolerate them, or have a type of tumor with no standard treatment.

Part B only:

  • Cohort A: Have advanced stomach or gastroesophageal cancer that hasn't been treated before, except for certain previous therapies if the cancer returned after 6 months.
  • Cohort B: Have stomach or gastroesophageal cancer that worsened after one or two previous treatments.
  • Cohort C: Have advanced pancreatic cancer that hasn't been treated before, except for certain previous therapies if the cancer returned after 6 months.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate heart, liver, and kidney function.

Exclusion Criteria

  • Have cancer that has spread to the brain and is causing symptoms.
  • Have been treated with drugs targeting CLDN18.2 before.
  • Have allergies to TST001 or similar drugs.
  • Have severe heart disease or recent heart problems.
  • Have another active cancer within the last 5 years, except for certain types.
  • Have active infections like hepatitis B, hepatitis C, or HIV.
  • Have any condition that the doctor thinks makes participation inappropriate.

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