OHSU Knight Cancer Institute
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.
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
Wee1 Inhibitor ZN-c3
Early Phase 1
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.
Study Type : | Interventional |
Estimated Enrollment : | 0 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Early Phase I Study of the Pharmacodynamics of WEE1 Inhibitor, ZN-c3, in Metastatic Solid Tumors |
Actual Study Start Date : | July 30, 2023 |
Estimated Primary Completion Date : | September 30, 2024 |
Estimated Study Completion Date : | July 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment (wee1 inhibitor ZN-c3) Patients receive Wee1 inhibitor ZN-c3 PO QD on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
Drug: Wee1 Inhibitor ZN-c3 |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.