Summary
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). BBI-825 is an oral, potent, selective ribonucleotide reductase (or RNR) small molecule inhibitor. This is a first-in-human, open-label, 2-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with BBI-825 or other select therapies.
Official Title
An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications
Details
BBI-355 and BBI-825 are administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.
Keywords
Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Carcinoma, High Grade Endometrial Carcinoma, Anogenital Cancer, Head and Neck (HNSCC), Cutaneous Squamous Cell Carcinoma (CSCC), Cervical Squamous Cell Carcinoma, ER+ Breast Cancer, Leiomyosarcoma (LMS), Undifferentiated Pleomorphic Sarcoma (UPS), Pancreatic Cancer Metastatic, Small Cell Lung Cancer, ecDNA, extrachromosomal DNA, Amplification, Oncogene Amplification, Checkpoint kinase 1, CHK1, RNR, ribonucleotide reductase, Carcinoma, Breast Neoplasms, Squamous Cell Carcinoma, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Endometrial Neoplasms, Leiomyosarcoma, Malignant Fibrous Histiocytoma, Erlotinib Hydrochloride, Futibatinib, BBI-355, Erlotinib, BBI-825