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Official Title

A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066)

Phase
Phase 2
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Enrollment
170
Timeline
Feb 2022 → Jun 2027
About This Study

This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.

Eligibility Criteria

Inclusion Criteria

  • 1Age ≥18 years
  • 2High-grade serous ovarian, fallopian tube or primary peritoneal cancer
  • 3Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
  • 4Prior therapy:
  • 5Subjects must have platinum-resistant disease
  • 6One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
  • 7Prior bevacizumab treatment is required, if eligible per standard of care
  • 8Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
  • 9Prior mirvetuximab treatment is required, if eligible per standard of care
  • 10Measurable disease per RECIST Version 1.1.
  • 11Adequate hematologic and organ function, as defined in protocol
  • 12ECOG 0-1

Exclusion Criteria

  • 1Primary platinum-refractory disease
  • 2Any of the following treatment interventions within the specified time frame prior to C1D1:
  • 3Major surgery within 28 days
  • 4Hospitalization within 14 days
  • 5Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
  • 6Radiation therapy within 21 days;
  • 7Autologous or allogeneic stem cell transplant within 3 months.
  • 8Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter).
  • 9Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to C1D1.
  • 10Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
  • 11A serious illness or medical condition(s) including, but not limited to:
  • 12Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
  • 13Myocardial impairment resulting in heart failure (NYHA Class II-IV)
  • 14Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results
  • 15Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
  • 16Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
  • 17Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before C1D1
  • 18Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
  • 19Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
  • 20Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
  • 21History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.
  • 22Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
  • 23Subjects with known active hepatitis B or hepatitis C infection.
  • 24Individuals who are judged by the Investigator to be unsuitable as study subjects.
  • 25Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

Locations

86 sites participating in this study

Site 0108 - Emory University Hospital

Atlanta, Georgia 30322

Recruiting

Jennifer Scalici

Site 0170-USA Mitchell Cancer Institute

Mobile, Alabama 36604

Recruiting

Jennifer Pierce

Site 0143 - HonorHealth

Phoenix, Arizona 85016

Recruiting

Lindsay Willmott

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →