Study on ZN-c3 and Gemcitabine for Pancreatic Cancer

Sponsor: Brandon Huffman

Sponsor score: 0

ClinicalTrials ID:NCT06015659

Provider View

This clinical trial is testing a new treatment that combines the experimental drug ZN-c3 with the approved drug Gemcitabine to see if it is safe and effective for people with advanced pancreatic cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining two drugs, ZN-c3 and Gemcitabine, for treating advanced pancreatic cancer. ZN-c3 is an experimental drug that has not yet been approved by the FDA, while Gemcitabine is already approved for treating advanced pancreatic cancer. Participants will undergo various procedures, including scans, blood tests, and tumor biopsies, to monitor their response to the treatment. The study aims to enroll about 34 participants and is supported by the Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer, with Zentalis providing the study drug ZN-c3.

Description

This study is an open-label, single-arm phase 2 trial, meaning all participants will receive the same treatment without a placebo group. The trial is designed to test the combination of ZN-c3, an experimental drug, with Gemcitabine in patients with advanced pancreatic cancer who have already tried other treatments. Participants will be screened for eligibility and will undergo various tests and evaluations throughout the study, including imaging scans, blood tests, and tumor biopsies. The study is expected to include about 34 participants. The Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer are funding the study, and Zentalis is providing the ZN-c3 drug.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced pancreatic cancer that cannot be cured with standard treatments.
  • Cancer must have worsened or not been tolerated after a platinum-based treatment.
  • Must have had no more than one previous line of platinum-based chemotherapy for metastatic cancer.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have adequate organ and bone marrow function, as shown by specific blood test results.
  • Must have measurable cancer and be willing to have tumor biopsies.
  • If you have chronic hepatitis B, the virus must be under control.
  • Must understand and agree to the study requirements and sign a consent form.
  • Women must not be pregnant and must use effective birth control during and after the study.
  • Men must agree to use condoms or abstain from sex during and after the study.
  • If you have had hepatitis C, it must be treated and cured.

Exclusion Criteria

  • Have previously received a WEE1 inhibitor.
  • Have received Gemcitabine for incurable pancreatic cancer or within 6 months of prior treatment.
  • Have used another anti-cancer drug recently.
  • Are taking certain medications or supplements that interact with the study drugs.
  • Have had major surgery recently.
  • Have significant side effects from previous treatments.
  • Cannot swallow pills or have certain digestive issues.
  • Have active or untreated brain cancer.
  • Have severe allergies to similar drugs.
  • Have uncontrolled illnesses or infections.
  • Have had another significant cancer in the past 2 years.
  • Are pregnant or breastfeeding.
  • Have certain heart conditions.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02215BostonMassachusetts

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