Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
Stopped early · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT05827614
- Run by
- Boundless Bio, Inc.
- People needed
- 85
- Starts
- 2023-03-24
- Expected to finish
- 2026-03-17
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- Sarcoma Oncology — Santa Monica, California, United States
- HealthONE — Denver, Colorado, United States
- Florida Cancer Specialists — Lake Mary, Florida, United States
- The University of Kansas — Fairway, Kansas, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- START Midwest — Grand Rapids, Michigan, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- SCRI Oncology Partners — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- NEXT Oncology - Dallas — Irving, Texas, United States
- NEXT Oncology — San Antonio, Texas, United States
- NEXT Oncology — Fairfax, Virginia, United States
- University of Washington, Fred Hutchinson Cancer Center — Seattle, Washington, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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