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of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Patients with one of the following histologically or cytologically confirmed advanced cancers:\n\nPhase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator):\n\n* HR+\u002FHER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n* Locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n* Metastatic castration-resistant prostate adenocarcinoma, with no documented neuroendocrine component, castrate level of testosterone, and no more than 3 prior lines of systemic therapy for metastatic disease.\n\nPhase II:\n\n* HR+\u002FHER2- aBC with disease progression on or after an endocrine therapy in combination, with a CDK4\u002F6 inhibitor for advanced disease with no more than 2 lines of endocrine therapy and no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease.\n\n  \\- Measurable disease as determined by RECIST v1.1.\n* BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n* metastatic Castration-Resistant Prostate Cancer (mCRPC) only: If no measurable disease is present per PCWG3 modified RECIST, then at least 1 metastatic lesion must be present on bone scan imaging.\n\nExclusion Criteria:\n\n* Patients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including myocardial infarction (MI), coronary artery bypass graft (CABG), long QT syndrome, or risk factors for Torsades de Pointes (TdP).\n* Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n* Patients with symptomatic visceral disease, including visceral crisis.\n* For patients with BC: Patient is concurrently using hormone replacement therapy.\n* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":192,"type":193},205,"ESTIMATED","INTERVENTIONAL",[196,197],"PHASE1","PHASE2","Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. 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