Open Actively Recruiting

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

About

Brief Summary

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). This is a first-in-human, open-label, 3-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 select therapies.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1/Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

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Study Stats
Protocol No.
24-5173
Category
Colorectal Cancer
Lung Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Stomach Cancer
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05827614
For detailed technical eligibility, visit ClinicalTrials.gov.