Phase 2 Study of ZN-c3 in High-Grade Serous Ovarian Cancer

Phase 1

Recruiting

Conditions: High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
MedDRA version: 20.0Level: LLTClassification code: 10033130Term: Ovarian cancer NOS Class: 10029104
MedDRA version: 21.0Level: LLTClassification code: 10016183Term: Fallopian tube cancer NOS Class: 10029104
MedDRA version: 20.0Level: LLTClassification code: 10052171Term: Peritoneal carcinoma Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2022-502983-19-00

Lead Sponsor: K-Group Beta Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 474

Inclusion Criteria

2. Age =18 years at the time of informed consent., 3. Histologically or cytologically confirmed recurrent, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer, 4. Subject must have platinum-resistant disease One to 4 prior lines or regimens are allowed in part 2 (no more than 5 in part 1b), 7. Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1., 8. Performance Status: Eastern Cooperative Oncology Group (ECOG) score of =1., 9. Adequate hematologic and organ function For the complete Inclusion Criteria, please refer to the study protocol

Exclusion Criteria

2. Any of the following treatment interventions within the specified time frame prior to C1D1: b. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter); c. Radiation therapy within 21 days; however, if the radiation portal covered =5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy. d. Autologous or allogeneic stem cell transplant within 3 months. e. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter)., 3. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor. g. Any evidence of small 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., 6. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade =2 neuropathy, alopecia or skin pigmentation). For the complete Exclusion Criteria, please refer to the study protocol