Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), in Subjects With Tumors With Oncogene Amplifications

Launched by BOUNDLESS BIO · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BBI-355, which is designed for patients with certain types of advanced cancers, such as non-small cell lung cancer, breast cancer, and bladder cancer. BBI-355 works by targeting specific changes in cancer cells that can make them grow uncontrollably. The trial aims to find out how safe this treatment is, how much of it can be given, and whether it works better alone or when combined with other therapies.

To participate, patients must have locally advanced or metastatic solid tumors that have not responded to standard treatments. They should have certain genetic features in their tumors, which can be determined through previous tests. Participants can expect to receive the treatment in a clinical setting, and the study will monitor their health and any side effects. This is an important step in finding new therapies for patients with few remaining options, and the trial is currently recruiting individuals aged 65 and older.

Gender

ALL

Eligibility criteria

• 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,
• • Single agent arm: Evidence of oncogene amplification,
• • BBI-355 combination with erlotinib arm: Evidence of amplification of wildtype EGFR,
• • BBI-355 combination with futibatinib arm: Evidence of amplification of wildtype FGFR1, FGFR2, FGFR3, or FGFR4,
• • 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:
• • Well-known tumor activating oncogene mutations or fusions,
• • Prior exposure to CHK1 inhibitors,
• • BBI-355 combination with erlotinib arm: Prior exposure to EGFR inhibitors,
• • BBI-355 combination with futibatinib arm: Prior exposure to FGFR inhibitors,
• • 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.