Study on the Safety and Effectiveness of CFI-402411 for Advanced Solid Tumors

Sponsor: Treadwell Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04521413

Provider View

This clinical trial is testing a new drug called CFI-402411, both on its own and combined with another drug, pembrolizumab, to see if it is safe and effective for patients with advanced solid tumors that have not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to evaluate the safety of a new drug, CFI-402411, when used alone or with pembrolizumab, in patients with advanced solid tumors that have not improved with previous treatments. CFI-402411 is a pill that may help the immune system fight cancer by blocking a protein called HPK1. The study will help determine the best dose and schedule for future research.

Description

This is the first study to test CFI-402411 in humans, focusing on its safety and how well patients tolerate it. The drug is being tested alone and in combination with pembrolizumab, a medication that helps the immune system attack cancer cells. CFI-402411 works by blocking a protein called HPK1, which may boost the body's immune response against tumors. Combining it with pembrolizumab could enhance this effect. The study will gather data to decide the best dose and schedule for future trials and identify which patients might benefit most from this treatment. Early research suggests that CFI-402411 could be a promising new cancer treatment, especially when used with pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced cancer that has not responded to 1 to 3 previous treatments.
  • Must have cancer that can be measured by scans or tests.
  • Must be in good general health, able to carry out normal activities or light work.

For specific parts of the study:

  • Must have a confirmed diagnosis of certain types of advanced cancer, such as lung cancer, melanoma, or breast cancer, among others.
  • Cancer must not respond to standard treatments or no standard treatments are available.
  • For some parts, patients must be eligible to receive pembrolizumab.
  • Optional biopsies may be required for some participants.

Exclusion Criteria

  • Have previously been treated with an HPK1 inhibitor in other studies.
  • Have autoimmune diseases or significant immune system disorders.
  • Have heart problems like heart failure, chest pain, or recent heart attack.
  • Have chronic irregular heartbeat.
  • Have cancer that has spread to the brain.
  • Have had a stroke or similar events in the last 3 months.
  • Have a history of heart rhythm problems or risk factors for heart issues.

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