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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
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

NCT05827614

TerminatedPhase 1

Sponsor: Boundless Bio, Inc.

Conditions: Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Carcinoma, High Grade Endometrial Carcinoma, Anogenital Cancer, Head and Neck (HNSCC)

Interventions: BBI-355, Erlotinib, Futibatinib, BBI-825

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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,
* 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.
Locations (16)
  • Los Angeles, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Lake Mary, Florida, United States
  • Fairway, Kansas, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • New York, New York, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Irving, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
  • Seattle, Washington, United States
  • Madison, Wisconsin, United States