NCT05368506

ZN-c3 for the Treatment of Metastatic Triple-Negative Breast Cancer and Advanced Ovarian Cancer

An Early Phase I Study of the Pharmacodynamics of WEE1 Inhibitor, ZN-c3, in Metastatic Solid Tumors

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial tests the safety and side effects of ZN-c3 in treating patients with triple-negative breast cancer or ovarian cancer that have spread to other parts of the body (metastatic or advanced). ZN-c3 is an enzyme inhibitor that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the primary pharmacodynamic effect of wee1 inhibitor ZN-c3 (ZN-c3) in tumor biopsies from patients with advanced triple-negative breast cancer (TNBC) and ovarian cancer. II. To assess safety and tolerability of the proposed therapy. SECONDARY OBJECTIVES: I. To assess clinical benefit of TNBC and ovarian cancer patient from the proposed therapy. II. To determine time to disease progression. III. To assess participant survival on study. EXPLORATORY OBJECTIVES: I. To evaluate ZN-c3 pharmacokinetics (PK). II. To identify predictive biomarkers of sensitivity to therapy. III. To identify emerging mechanisms of resistance to therapy. OUTLINE: Patients receive Wee1 inhibitor ZN-c3 orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for to 1 year.

Conditions

• Advanced Fallopian Tube Carcinoma
• Advanced Ovarian Carcinoma
• Advanced Primary Peritoneal Carcinoma
• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Triple-Negative Breast Carcinoma
• Stage III Fallopian Tube Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Primary Peritoneal Cancer AJCC v8
• Stage IV Fallopian Tube Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Primary Peritoneal Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Wee1 Inhibitor ZN-c3	Given PO

Timeline

• Start date: 2023-07-30
• Primary completion: 2024-09-30
• Completion: 2025-07-31
• First posted: 2022-05-10
• Last updated: 2023-05-06

Regulatory

• FDA-regulated drug study