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:

* Other inclusion criteria per study protocol.

Key Exclusion Criteria:

* 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.