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A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

PHASE2RECRUITING

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.

Study details:

A Phase 2 study to evaluate the efficacy and safety of azenossertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage leading to mitotic catastrophe and cancer cell death.

The study consists of two parts:. Part 1: All comers, no biomarker status required (completed enrollment). Part 2: Cyclin E1 positive protein expression required.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  1. Primary platinum-refractory disease
  2. Any of the following treatment interventions within the specified time frame prior to C1D1:
  3. Major surgery within 28 days
  4. Hospitalization within 14 days
  5. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
  6. Radiation therapy within 21 days;
  7. Autologous or allogeneic stem cell transplant within 3 months.
  8. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
  9. Inability 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.
  10. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
  11. A serious illness or medical condition(s) including, but not limited to:
  12. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
  13. Myocardial impairment resulting in heart failure (NYHA Class II-IV)
  14. Severe 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
  15. Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
  16. Significant 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.
  17. Active, 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
  18. Any 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.
  19. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
  20. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
  21. History 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.
  22. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
  23. Subjects with known active hepatitis B or hepatitis C infection.
  24. Individuals who are judged by the Investigator to be unsuitable as study subjects.
  25. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE2

trial

Study ID

NCT05128825

Intervention or treatment

DRUG: azenosertib

Conditions

  • High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

  • Condition: High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

  • DRUG: azenosertib

  • Brisbane, Queensland, Australia and more

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

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Site 2715 - Icon Cancer Centre - Chermside

Select from list below to view details:

  • Site 2715 - Icon Cancer Centre - Chermside

    Brisbane, Queensland, Australia

  • Site 2707 - Mater Brisbane

    South Brisbane, Queensland, Australia

  • Site 2709 - Icon Cancer Research Adelaide

    Adelaide, South Australia, Australia

  • Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre

    Toorak Gardens, South Australia, Australia

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Who is running the clinical trial?

KBIawosoZPI

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1a/1b (Completed Enrollment)
  • Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.
Drug: azenosertib
    EXPERIMENTAL: Part 2a: Arm 1 (Completed Enrollment)
    • Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
    Drug: azenosertib
      EXPERIMENTAL: Part 2a: Arm 2 (Completed Enrollment)
      • Azenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule
      Drug: azenosertib
        EXPERIMENTAL: Part 2b (Completed Enrollment)
        • Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
        Drug: azenosertib
          EXPERIMENTAL: Part 2c (Enrolling)
          • Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
          Drug: azenosertib

            What is the study measuring?

            Primary Outcome

            MeasureDescriptionTime Frame
            Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.Up to approximately 12 months from the enrollment of the last subject

            Secondary Outcome

            MeasureDescriptionTime Frame
            Duration of response (DOR) defined by RECIST v1.1 [Part 2]Time from the date of first documented response (CR or PR that is subsequently confirmed per RECIST v1.1) until the date of progressive disease (PD) or death.Up to approximately 12 months from the enrollment of the last subject
            Progression free survival (PFS) defined by RECIST v1.1 [Part 2]Time from the date of first dose until the date of PD or death.Up to approximately 12 months from the enrollment of the last subject
            Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2]The percentage of participants who have at least 1 confirmed response of CR or PR, or stable disease for at least 16 weeks before any evidence of progression.Up to approximately 12 months from the enrollment of the last subject
            CA-125 response by GCIG criteria [Part 2]The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline.Up to approximately 12 months from the enrollment of the last subject
            Number of Subjects experiencing treatment emergent adverse events (TEAEs) [Part 2]Not SpecifiedUp to approximately 12 months from the enrollment of the last subject
            Are you running this trial?If you're a clinic or sponsor, you can claim this study.
            Claim this trial

            References

            Clinical Trials Gov: A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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