An Early Phase I Study of the Pharmacodynamics of WEE1 Inhibitor, ZN-c3, in Metastatic Solid Tumors
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.
• Participant must provide written informed consent before any study-specific procedures or interventions are performed
• Participants aged \>= 18 years
• Participants with biopsy proven metastatic TNBC defined as:
‣ Estrogen receptor (ER) \< 10%, progesterone receptor (PR) \< 10%
⁃ HER2 non-amplified by College of American Pathologists (CAP) guidelines
• Participants with biopsy proven advanced ovarian cancer (including primary peritoneal and fallopian tube cancers)
• Prior PARP inhibitor therapy allowed
• Participants must have at least one measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 that is amendable to biopsy
• Participants must have received at least one standard of care line of therapy in the recurrent setting
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
• Prior treatment related toxicities resolved to =\< grade 1 (except neuropathy, alopecia or skin pigmentation)
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim
• Platelet count \>= 100 x 10\^9/L; excluding measurements obtained within 3 days after transfusion of platelets
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT =\< 5 x ULN
• Total serum bilirubin =\< 1.5 x ULN or =\< 3 x ULN in the case of Gilbert's disease
• Serum creatinine =\< 1.5 x ULN or creatinine clearance (CrCl) \>= 60 mL/min
• Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-hCG) test
• Participants of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of ZN-c3
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, including pretreatment and on-treatment biopsies
• Willingness to practice adequate sun protection (use of sunscreen or sun-protective clothing or limitation of sun exposure)