Study on TU2218 and Pembrolizumab Combination for Advanced Solid Tumors

Sponsor: TiumBio Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05784688

Provider View

This clinical trial is testing a new treatment combining TU2218 and Pembrolizumab to see if it is safe and effective for patients with advanced solid tumors. The study is divided into two phases to determine the best dose and evaluate the treatment's ability to shrink tumors.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new treatment combining TU2218 and Pembrolizumab in patients with advanced solid tumors. The first phase (1b) focuses on finding the right dose, while the second phase (2a) assesses how well the treatment works in shrinking tumors in three specific types of cancer.

Description

The primary objective of phase 1b is to determine the recommended phase 2 dose of the combination (RP2DC) of TU2218 given with pembrolizumab in advanced solid tumors.

The primary objective of phase 2a is to evaluate the efficacy of TU2218 administered in combination with pembrolizumab in selected advanced tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Expected to live at least 12 more weeks.
  • Have a measurable tumor.
  • Good overall health with an ECOG score of 0 or 1.
  • Able to swallow pills.
  • Have an advanced solid tumor that cannot be removed by surgery and has not responded to standard treatments.
  • For cervical cancer group: Must have cervical cancer that has progressed after at least one treatment.
  • For bile duct cancer group: Must have bile duct cancer that has not been treated with certain immunotherapies and has progressed after standard treatments.
  • For colorectal cancer group: Must have a specific type of colorectal cancer that has progressed after at least two standard treatments.
  • Good blood, liver, and kidney function based on specific tests.
  • Able to understand and follow study instructions.
  • Normal heart function and ECG results.
  • No other cancer treatments recently.
  • Not pregnant or breastfeeding, and willing to use birth control if of childbearing potential.

Exclusion Criteria

  • Recent heart attack or heart surgery.
  • Severe heart conditions or uncontrolled high blood pressure.
  • Brain or central nervous system cancer spread.
  • Difficulty swallowing or absorbing medication.
  • Tumors that may cause bleeding.
  • Severe bleeding history or unable to stop blood thinners.
  • Severe heart valve issues or aneurysms.
  • Pregnant or breastfeeding women.
  • Previous severe reactions to similar treatments.
  • Recent cancer treatments or participation in other clinical trials.
  • Active infections or immune system issues.
  • Severe allergies to study drugs.
  • Any condition that may interfere with the study or participant's safety.

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