Phase 1/2 Study of ZN-c3 and Niraparib and ZN-c3 Monotherapy in Platinum-Resistant Ovarian Cancer

Prior treatment

• Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration).
• Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter)
• A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.
• Any investigational drug therapy <28 days.
• Prior treatment with a WEE1 inhibitor.
• Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV). Significant gastrointestinal abnormalities, requirement for IV 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.

Other illness

• Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.
• Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg).

• Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.
• Subjects must have platinum-resistant disease.
• Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.
• Adequate hematologic and organ function.
• Ability and willingness to take oral medication.
• Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.