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

Cancer Categories

Gastrointestinal (GI),Gynecologic

Karmanos Trial ID

GOG-3066

NCT ID

NCT05128825

Age Group

Adult

Scope

National

Phase

Phase II

Principal Investigator

Robert
Morris, M.D.
Oncology - Gynecologic, Oncology - Surgical View Profile

Objective:

Primary Objectives:

Part 1b:

To determine the safety and tolerability of ZN-c3 in subjects with PROC

Part 2:

To investigate the antitumor activity of ZN-c3 in subjects with PROC

Secondary Objectives:

Part 1b:

To investigate the antitumor activity of ZN-c3 in subjects with PROC at different doses/schedules
To investigate the plasma PK of ZN-c3

Part 2:

To further investigate the antitumor activity of ZN-c3 in subjects with PROC
To investigate the safety and tolerability of ZN-c3 in subjects with PROC
To investigate the plasma PK of ZN-c3

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Eligibility

Inclusion Criteria:

Age ≥18 years
High-grade serous ovarian, fallopian tube or primary peritoneal cancer
Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
Prior therapy:

Subjects must have platinum-resistant disease
One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
Prior bevacizumab treatment is required, if eligible per standard of care
Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
Prior mirvetuximab treatment is required, if eligible per standard of care

Measurable disease per RECIST Version 1.1.
Adequate hematologic and organ function, as defined in protocol
ECOG 0-1

Exclusion Criteria:

Primary platinum-refractory disease
Any of the following treatment interventions within the specified time frame prior to C1D1:

Major surgery within 28 days
Hospitalization within 14 days
Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
Radiation therapy within 21 days;
Autologous or allogeneic stem cell transplant within 3 months.
Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
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.

Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
A serious illness or medical condition(s) including, but not limited to:

Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
Myocardial impairment resulting in heart failure (NYHA Class II-IV)
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
Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
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.
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
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.

Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
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.
Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
Subjects with known active hepatitis B or hepatitis C infection.
Individuals who are judged by the Investigator to be unsuitable as study subjects.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices