Study on CT7439 for Patients with Solid Tumors

Sponsor: Carrick Therapeutics Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06600789

Provider View

This clinical trial is testing the safety and tolerability of a new drug, CT7439, both on its own and in combination with other cancer treatments, for patients with solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate how safe and tolerable CT7439 is when given to patients with solid tumors. It will start by testing CT7439 alone to find the best dose that is both effective and safe. The study will be conducted in different parts, with each part focusing on different aspects of the treatment. Participants will continue to receive the treatment until their cancer progresses, they experience unacceptable side effects, or they choose to leave the study. Additional groups of patients may be included as the study progresses.

Description

This study will first test CT7439 alone in patients with advanced solid tumors. The initial phase, called Part A, will determine the safest and most effective dose of CT7439. A group of experts will monitor the safety and effects of the drug throughout this phase. Participants will receive the drug until their cancer worsens, they experience severe side effects, or they decide to stop participating. The study may expand to include more specific groups of patients after initial results are reviewed.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer that can be measured by standard criteria.
  • Agree to provide written consent and follow all study procedures, including visits and tests.
  • Have a performance status score of 2 or less, indicating they are able to carry out light work.
  • Be able to take oral medications and keep a daily record of taking the study drug.
  • Women must either be unable to have children or agree to use effective birth control during the study and for 33 days after the last dose.
  • Men must agree to use condoms and refrain from donating sperm during the study and for 93 days after the last dose.
  • Have an estimated life expectancy of at least 3 months.

Exclusion Criteria

  • Have previously received a specific CDK12/13 inhibitor.
  • Have another active or recently treated cancer within the past 3 years, except for certain skin or cervical cancers.
  • Have unresolved side effects from previous treatments that are severe.
  • Have a history of autoimmune disease.
  • Have current or past cancer spread to the brain or spinal cord.
  • Have an active infection requiring treatment within 14 days before starting the study drug.
  • Have severe or uncontrolled medical or psychiatric conditions.
  • Have HIV unless stable on treatment and without recent infections.
  • Have active hepatitis B or C unless under control with treatment.
  • Be pregnant or breastfeeding.
  • Have received cancer treatment within 28 days before starting the study drug.
  • Have taken corticosteroids within 14 days before starting the study drug.
  • Have taken certain medications or supplements that affect liver enzymes within 21 days before starting the study drug.
  • Have inadequate liver, kidney, or bone marrow function, or have had a blood transfusion within 14 days before starting the study drug.
  • Have severe low blood cell counts due to previous treatment.
  • Have a history of heart problems or significant cardiovascular disease.
  • Have received a live vaccine within 28 days before starting the study.

Additional criteria for Module 1:

  • Have advanced solid tumors with no curative treatment options available.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.