Study of IEV407 as single agent or in combination in patients with advanced HR+/HER2- breast cancer (CIEV407A12101)

未提供0 个研究点目标入组 8 人开始时间: 待定

适应症

试验速览

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•Age >= 18 years old
•Patients with one of the following indications:
•Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at leaset one line of endocrine-based therapy in combination with a CDK4/6 inhibitor and at least one additional line of systemic therapy in the unresectable/metastatic setting and not be a candidate for any available standard therapy, in the investigator judgement.
•Dose expansion of IEV407 in combination with fulvestrant: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4/6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting. Prior cytotoxic chemotherapy and/or antibody-drug conjugate therapies in the unresectable/metastatic setting are not allowed.

•Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
•Impaired cardiac function or clinically significant cardiac disease.
•Concurrent use of hormone replacement therapy.
•Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.
•For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.

发起方

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