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
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.
Checked against the public recordLast updated Aug 19, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Boundless Bio, Inc.
- Interventions being studied
- Drug: BBI-355; Drug: Erlotinib; Drug: Futibatinib; Drug: BBI-825
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * 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, * Other inclusion criteria per study protocol. Key Exclusion Criteria: * 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, * Other exclusion criteria per study protocol.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Medical CenterLos Angeles, California
- Sarcoma OncologySanta Monica, California
- HealthONEDenver, Colorado
- Florida Cancer SpecialistsLake Mary, Florida
- The University of KansasFairway, Kansas
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- START MidwestGrand Rapids, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- SCRI Oncology PartnersNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas
- NEXT Oncology - DallasIrving, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 19, 2026. Always confirm current availability with the study team.