Pilot Study on TPST-1495 for Patients with Endometrial and Colorectal Cancer Needing Surgery

Sponsor: University of Oklahoma

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06129604

Provider View

This clinical trial is testing a new drug, TPST-1495, to see if it can help the immune system fight endometrial and colorectal cancer in patients who are scheduled for surgery. Researchers will examine blood and tumor samples before and after treatment to evaluate its effectiveness.

Patient Parameters

Program Overview

The study aims to find out if TPST-1495, a new drug, can help treat endometrial and colorectal cancer by boosting the immune system. Patients will take the drug for seven days before their surgery, and researchers will check blood and tumor samples to see how well it works. The trial will include up to 20 participants, with 10 patients being evaluated for results.

Description

TPST-1495 is a new drug that targets specific receptors in the body and has shown potential in early research to help the immune system fight cancer. This study will test its safety and effectiveness in patients with endometrial or colorectal cancer who are scheduled for surgery. Participants will take 50mg of TPST-1495 by mouth once a day for seven days, stopping three days before their surgery. The study will include 10 patients who can be evaluated, with five from each cancer group, and up to 20 participants in total to ensure enough data is collected. Researchers will look at how the drug affects the cancer by analyzing blood and tumor samples taken before and after the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Be at least 18 years old.
  • Have a confirmed diagnosis of endometrial or colorectal cancer, either newly diagnosed or recurring, but not previously treated with chemotherapy or radiation.
  • Be eligible for surgery.
  • Both men and women can participate. Those with partners who can become pregnant must use two effective birth control methods during the study and for three months after.
  • Women must take a pregnancy test before starting the study and after finishing treatment.
  • Men should not donate sperm during the study and for three months after.
  • Must have a tumor sample available or agree to a biopsy to obtain one.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a life expectancy of more than 12 weeks.
  • Have adequate organ and bone marrow function as defined by the study.

Exclusion Criteria

  • Participating in another clinical study, unless it's observational or involves specimen collection.
  • Use of NSAIDs or COX-2 inhibitors for four days or more within two weeks before starting the study.
  • History of allergies or sensitivity to NSAIDs or COX-2 inhibitors, or gastrointestinal bleeding or ulcers caused by these medications.
  • History of gastrointestinal ulcers within a year or untreated Helicobacter pylori infection. Treated and confirmed eradicated infections are allowed.
  • History of diverticulitis or gastrointestinal bleeding within two years.
  • Heart failure classified as NYHA Class II, III, or IV.
  • History of heart attack or stroke.
  • Active autoimmune or inflammatory diseases requiring systemic treatment within two years.
  • Uncontrolled illnesses, including infections, heart failure, high blood pressure, unstable chest pain, heart rhythm problems, serious gastrointestinal issues, or psychiatric conditions that could affect study participation.
  • Receiving anticoagulant therapy or at increased risk of bleeding.
  • Conditions that prevent compliance with study procedures.
  • Other cancers that could interfere with the study's safety or effectiveness assessments.

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