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

Lead Sponsor

Boundless Bio, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists,
•Evidence of oncogene amplification,
•Availability of FFPE tumor tissue, archival or newly obtained,
•Measurable disease as defined by RECIST Version 1.1,
•Adequate hematologic function,
•Adequate hepatic and renal function,
•Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,

•Single agent arm: Prior exposure to CHK1 or WEE1 inhibitors,
•BBI-355 combination with BBI-825 arm: Prior exposure to combination therapy of any RNR inhibitor plus CHK1/2 inhibitor,
•Hematologic malignancies,
•Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
•Prior or concurrent malignancies, with exceptions per study protocol,
•History of HBV, HCV, or HIV infection,
•Clinically significant cardiac condition,
•Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
•QTcF \> 470 msec,
•Prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation,

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