Brief Title: ZN-c3 in Participants With Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose Escalation

Primary Outcome 1 - Timeframe: Through completion

Primary Outcome 2 - Measure: Food Effect Cohort

Primary Outcome 2 - Timeframe: average of 1 year

Primary Outcome 3 - Measure: Food Effect Cohort

Primary Outcome 3 - Timeframe: Through completion

Primary Outcome 4 - Measure: Food Effect Cohort

Primary Outcome 4 - Timeframe: approx 6 months

Primary Outcome 5 - Measure: Food Effect Cohort

Primary Outcome 5 - Timeframe: Through completion

Primary Outcome 6 - Measure: Dose Expansion

Primary Outcome 6 - Timeframe: approximately 6 months

CONDITION

• Solid Tumor

ELIGIBILITY

Major Eligibility Criteria:
1. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.

- 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

- 3. Adequate hematologic and organ function.

- 4. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception and for 6 months and 90 days, respectively, after the last dose of ZN-c3.
Dose Escalation Inclusion Criteria:
1. Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).

- 2. Measurable or evaluable disease per RECIST version 1.1.
Food Effect Cohort Inclusion Criteria:
1. Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available.

- 2. Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study.
Dose Expansion Inclusion Criteria:
1. Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.

- 2. Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
Major Exclusion Criteria:
1. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3.

- 2. Prior therapy with a WEE1 inhibitor.

- 3. A serious illness or medical condition(s).

- 4. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).

- 5. Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to C1D1.

- 6. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

- 7. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.

- 8. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Philippe Pultar, MD

Role: Study Director

Affiliation: K-Group Beta, a Zentalis Company

Overall Contact

Name: Project Director

Phone: 858-263-4333

Email: [email protected]

LOCATION