Testing the Combination of Anti-Cancer Drugs ZEN-3694 and Talazoparib in Patients with Advanced Solid Tumors (The ComBET Trial)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05327010

Provider View

This clinical trial is exploring whether a combination of two drugs, ZEN-3694 and Talazoparib, can help shrink tumors in patients with advanced solid tumors that are difficult to treat. The study also aims to understand how patients' genes might affect their response to this treatment.

Patient Parameters

Program Overview

This study is testing a new treatment using two drugs, ZEN-3694 and Talazoparib, to see if they can shrink tumors in patients with advanced solid tumors that have spread and are hard to treat. Researchers are also looking at how patients' genes might influence their response to this treatment. ZEN-3694 works by blocking proteins that help cancer cells grow, while Talazoparib stops cancer cells from repairing their DNA, causing them to die. The study will involve collecting tumor and blood samples to understand the genetic factors involved.

Description

The main goal of this study is to see how well the combination of ZEN-3694 and Talazoparib works in shrinking tumors. Researchers will measure the response rate, which includes complete and partial responses to the treatment.

Secondary goals include:

  • Checking the safety and side effects of the drug combination.
  • Evaluating how long patients benefit from the treatment and how long they live without the disease getting worse.
  • Studying changes in tumor samples before and after treatment to understand how the drugs work.
  • Identifying markers that might predict how well patients respond to the treatment.

Patients will take ZEN-3694 and Talazoparib pills daily in 28-day cycles. They will have regular scans and provide blood and tumor samples during the study. After finishing the treatment, patients will be followed up for 30 days and then every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer that has spread or cannot be removed by surgery, and for which no standard treatments are available or effective.
  • Have a tumor that can be safely biopsied and at least one measurable site of disease.
  • Be part of specific patient groups based on genetic mutations and previous treatments.
  • Have received at least one line of treatment for advanced cancer.
  • Be 18 years or older.
  • Be at least 4 weeks past any previous cancer treatments and have recovered from side effects.
  • Have a good performance status, meaning they can carry out daily activities with minimal assistance.
  • Have adequate blood counts and organ function.
  • Be HIV-negative or have controlled HIV, hepatitis B, or hepatitis C infections.
  • Have stable brain metastases if previously treated.
  • Not have other cancers that interfere with the study.
  • Agree to use effective birth control during and after the study.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Be taking other experimental drugs.
  • Have allergies to similar drugs as ZEN-3694 or Talazoparib.
  • Be taking certain medications that interact with the study drugs.
  • Have uncontrolled illnesses or psychiatric conditions that affect study participation.
  • Be pregnant or breastfeeding.
  • Be involved in the study's planning or conduct.
  • Be unable to swallow pills.
  • Have active infections requiring IV antibiotics.
  • Be taking certain blood thinners.
  • Have had extensive radiation or certain treatments recently.
  • Have had recent major surgery or heart issues.

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