Open Label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors That are Benefiting from Continuation of Therapy with Sacituzumab Govitecan - IMMU-132-14

Gilead Sciences Inc.0 个研究点目标入组 25 人开始时间: 2023年8月10日最近更新: 2024年8月21日

适应症

试验速览

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•Subjects meeting all the following inclusion criteria at Screening/Day -1 of treatment will be eligible for participation in the study., Female or male subjects, =18 years of age, able to understand and give written informed consent, Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study, Continuing to receive clinical benefit from sacituzumab govitecan therapy, Creatinine clearance = 30 mL/min as assessed by the Cockcroft-Gault equation, Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 4.

•Subjects meeting any of the following exclusion criteria at Screening/Day -1 of treatment will not be enrolled in the study., Women who are pregnant or lactating (Appendix 4), Initiated therapy with another cancer therapeutic agent (investigational or standard of care) since receiving the last dose of the study drug on the parent study in which they participated, Experienced a toxicity from sacituzumab govitecan that resulted in permanent discontinuation of therapy, Have an active serious infection requiring IV antibiotics (Contact medical monitor for clarification), Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations

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