CTIS2023-507324-23-00进行中（未招募）1 期
A Phase 2 Open-label, multicenter study to evaluate efficacy and safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma - ZN-c3-004
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
入选标准
- •1.Provision of signed informed consent prior to initiation of any study related procedures 2.Females =18 years old 3.Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject •Endometrial carcinoma of mixed histology where the serous component = 5% of the tumor •Carcinosarcomas (even with a serous component) are not eligible 4.ECOG PS 0 or 1, 5.Measurable disease per RECIST 1.1 criteria that has not been previously irradiated or has progressed following radiation therapy 6.Required prior therapy for endometrial cancer: •platinum-based chemotherapy regimen •PD-(L)1 inhibitor, except for subjects who are not clinically eligible in the opinion of the Investigator, or in regions where it is unavailable. •Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible in the opinion of the Investigator, or in regions where it is unavailable 7.FFPE tumor tissue block collected within 3 years prior to ICF, 8.Adequate hematologic and organ function during the Screening period, as defined: •ANC =1.5 × 109/L •Hgb =9.0 g/dL without PRBC transfusion in the prior 14 days •Platelet count =100 × 109/L •ALT and aspartate aminotransferase AST =3 × ULN;AST and ALT =5 × ULN if abnormalities are due to liver metaseses •Total serum bilirubin =1.5 × ULN or =3 × ULN in the case of Gilbert’s Syndrome •CrCl =30 mL/min based on Cockcroft-Gault method 9.Females of childbearing potential must agree to use an effective method of contraception prior to the first dose and for at least 6 months after the last dose of ZN c3. For determination of effective methods of contraception, refer to Section 12.1 10.Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •1.Any of the following treatment interventions within the specified time frame prior to C1D1: •Major surgery within 28 days and any preplanned major surgery during the study treatment period. •Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter). •Radiation within 21 days. •Autologous or allogeneic stem cell transplant within 3 months. •Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter) •Inability to discontinue treatment with drugs, or to discontinue food and herbal supplements, that are strong or moderate CYP3A inhibitors and inducers, or P-gp inhibitors at least 14 days prior to start of study drug treatment. Mandatory anti-emetics that may be CYP3A inhibitors are an exception to this criterion 2.Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor 3.Known hypersensitivity to ZN-c3 or any of the inactive ingredients in ZN-c3, 4.A serious illness or medical condition(s) including, but not limited to, the following: •Brain metastases that require immediate treatment or are clinically or radiologically unstable •Leptomeningeal disease that requires or is anticipated to require immediate treatment •Myocardial impairment of any cause resulting in heart failure by New York Heart Association Criteria (Class III or IV) •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study •Significant gastrointestinal abnormalities, considered to be clinically significant in the judgrior to C1D1, rement of the Investigator, or prior surgical procedures affecting absorption •Active, uncontrolled systemic infection. •Any evidence of bowel obstruction , recent hospitalization for bowel obstruction within 3 months prior to C1D1, or paracentesis/ thoracentesis within 3 weeks pcurrent paracentesis or thoracentesis within 6 weeks prior to C1D1 5, or paracentesis/thoracentesis anticipated during C1.Unresolved toxicity of Grade >1 attributed to any prior therapies, 6.Pregnant or lactating females or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to C1D1 7.History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. 8.Individuals who are judged by the Investigator to be unsuitable as study subjects
研究者
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