Study on Azenosertib (ZN-c3) for Patients with Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Sponsor score: 0

ClinicalTrials ID:NCT05128825

This clinical trial is testing a new drug, azenosertib (ZN-c3), to see if it is safe and effective for treating patients with certain types of ovarian, fallopian tube, or primary peritoneal cancer that have not responded to platinum-based treatments.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of azenosertib (ZN-c3) in patients with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum-based chemotherapy. The study is divided into two parts. Part 1 has already been completed and did not require specific biomarker status. Part 2 focuses on patients whose tumors test positive for Cyclin E1 protein, as determined by a special test used in the study.

Description

Azenosertib (ZN-c3) is a new drug that targets a protein called WEE1, which helps cancer cells repair themselves. By blocking WEE1, azenosertib may prevent cancer cells from repairing, leading to their death. This study is in Phase 2 and is testing the drug's safety and effectiveness in patients with certain types of cancer that have not responded to platinum-based treatments. The study has two parts: Part 1, which is completed, and Part 2, which requires patients to have tumors that test positive for Cyclin E1 protein.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
  • Tumors must test positive for Cyclin E1 protein using a specific test.
  • Cancer must be resistant to platinum-based treatments.
  • Have had 1 to 3 previous treatment regimens (up to 4 if previously treated with mirvetuximab).
  • Must have received bevacizumab, if eligible.
  • Must have received a PARP inhibitor if there is a BRCA 1/2 mutation or HRD, if eligible.
  • Must have received mirvetuximab, if eligible.
  • Must have measurable disease according to specific criteria.
  • Must have adequate blood and organ function.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Cancer that did not respond to initial platinum-based treatment.
  • Recent major surgery, hospitalization, or certain treatments within specified time frames before starting the study.
  • Previous treatment with ZN-c3 or similar drugs.
  • Serious medical conditions, including unstable brain metastases, heart failure, severe infections, or significant gastrointestinal issues.
  • Unresolved side effects from previous treatments, except for mild neuropathy, hair loss, or skin changes.
  • Pregnant or breastfeeding women, or women who could become pregnant and have a positive pregnancy test.
  • History of another cancer in the past 2 years, unless treated and disease-free.
  • Known immunocompromised status or active hepatitis B or C infection.
  • Judged unsuitable for the study by the investigator.
  • Previous extensive radiation therapy affecting a large portion of the bone marrow.

Locations

FACILITYZIPCITYSTATE
Site 0170-USA Mitchell Cancer Institute36604MobileAlabama
Site 0143 - HonorHealth85016PhoenixArizona
Site 0258 - UC San Diego Moores Cancer Center92037La JollaCalifornia
Site 0287 - Ridley Tree Cancer Center93105Santa BarbaraCalifornia
Site 0135 - Rocky Mountain Cancer Centers80218Lone TreeColorado
Site 0239 - Florida Cancer Specialists - East32117Daytona BeachFlorida
Site 0173 - Mount Sinai Medical Center33140Miami BeachFlorida
Site 0236 - Memorial Health31404SavannahGeorgia
Site 0284 - Community Health Network46250IndianapolisIndiana
Site 0251 - Norton Cancer Institute40202LouisvilleKentucky

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