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
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Keep this study
Lead
Boundless Bio, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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,
You may not be if
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,
Clareo Health | 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
