Study on TU2218 Alone and with Checkpoint Inhibitors for Advanced Solid Tumors

Sponsor: TiumBio Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05204862

Provider View

This clinical trial is testing a new drug, TU2218, both by itself and in combination with other drugs, to see if it is safe and effective for treating advanced solid tumors. The study aims to find the best dose and evaluate how well the treatment works against tumors.

Patient Parameters

Program Overview

The study is divided into two parts: Part A tests TU2218 alone, and Part B tests it in combination with other drugs. The main goal of Phase 1 is to find the best dose of TU2218 for future studies, while Phase 2 focuses on how well the drug works in shrinking tumors in patients with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a life expectancy of at least 12 weeks.
  • Have a measurable tumor as per specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Able to swallow capsules.
  • Have an advanced solid tumor that has not responded to standard treatments or for which no effective standard treatment exists.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1500 cells/μL.
    • Platelet count of at least 100,000/μL.
    • Hemoglobin level of at least 9.0 g/dL.
    • Normal blood clotting times.
    • Liver and kidney function within specified limits.
  • Able to understand and comply with study requirements.
  • Have a normal heart rhythm and function.
  • Have completed any previous cancer treatments and recovered from any side effects.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study.

Exclusion Criteria

  • Recent heart attack or heart surgery within the past 6 months.
  • Unstable heart conditions or recent stroke.
  • Severe heart failure or irregular heartbeats.
  • Uncontrolled high blood pressure.
  • Active infections, including hepatitis B, hepatitis C, or HIV.
  • History of lung inflammation or diseases.
  • Uncontrolled cancer spread to the brain or other severe conditions.
  • Difficulty swallowing or absorbing medications.
  • Previous treatment targeting TGF-β pathway.
  • Tumors that may cause bleeding.
  • History of severe bleeding or unable to stop blood thinners.
  • Regular use of high-dose aspirin or certain other medications.
  • Severe heart valve problems or aneurysms.
  • Active infection requiring antibiotics.
  • Recent live vaccines.
  • Use of certain medications that affect drug metabolism.
  • Use of stomach acid-reducing medications.
  • Use of herbal supplements.
  • Substance abuse or allergy to study drugs.
  • Recent major surgery or planned surgery during the study.
  • Women who are pregnant or breastfeeding.
  • Unable to use effective birth control.

For the combination therapy part:

  • Unable to stop steroid or immunosuppressive medications.
  • Use of high-dose steroids.
  • Active or history of autoimmune diseases, except certain conditions.

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