Study on PTT-936 Alone or Combined with Other Treatments for Advanced Solid Tumors

Sponsor: Pyrotech Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06244992

Provider View

This clinical trial is testing a new drug, PTT-936, to see if it is safe and effective for treating advanced solid tumors. The study will look at PTT-936 both by itself and in combination with other cancer treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment called PTT-936 for patients with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body. The trial is divided into two parts. In the first part, researchers will determine the safest dose of PTT-936 when used alone. In the second part, they will test how well PTT-936 works when combined with another type of cancer treatment called anti-PD-1/L1 therapy. The goal is to see if PTT-936 can help slow down or stop the growth of tumors.

Eligibility Criteria

Inclusion Criteria

  • Must voluntarily agree to participate and sign a consent form.
  • Be willing and able to follow all study procedures.
  • Be 18 years or older.
  • Have a confirmed diagnosis of a solid tumor that is advanced or has spread.
  • For Part A: Have tumors that can be seen on scans, whether they are measurable or not. For Part B: Have at least one tumor that can be measured on scans.
  • Have a life expectancy of at least 3 months.
  • Be in good general health, with a performance status score of 0 or 1.
  • Have adequate organ function, as shown by specific blood tests:
    • Neutrophil count of at least 1500/μL without support.
    • Platelet count of at least 90,000/μL without recent transfusion.
    • Hemoglobin level of at least 9 g/dL.
    • Creatinine clearance of at least 60 mL/min.
    • Liver enzymes (AST and ALT) no more than 3 times the normal limit.
    • Total bilirubin no more than 1.5 times the normal limit.
    • Normal blood clotting times unless on stable anticoagulation therapy.

Exclusion Criteria

  • Have cancer that has spread to the brain or spinal cord, unless treated and stable for at least 4 weeks.
  • Have had another type of cancer within the last 3 years, except for certain non-threatening cancers.
  • Have unresolved side effects from previous cancer treatments, or a history of severe immune-related side effects.
  • Have an active autoimmune disease or a history of autoimmune disorders that could flare up.
  • Have had major surgery or trauma within the last 4 weeks.
  • Have serious wounds or fractures that are not healing.
  • Have a history of certain heart or blood vessel problems within the last year.
  • Have uncontrolled high blood pressure.
  • Have a bleeding disorder or recent significant bleeding.
  • Have uncontrolled diabetes.
  • Have severe liver disease or cirrhosis.
  • Have a history of alcohol or drug abuse within the last year.

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