Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05827614

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

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
85 (actual)
Sponsor
Boundless Bio, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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). 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.

Detailed description

BBI-355 and BBI-825 are administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

Conditions

Interventions

TypeNameDescription
DRUGBBI-355Oral CHK1 inhibitor
DRUGErlotinibEGFR Inhibitor
DRUGFutibatinibFGFR1-4 Inhibitor
DRUGBBI-825Oral RNR Inhibitor

Timeline

Start date
2023-03-24
Primary completion
2026-09-30
Completion
2027-03-31
First posted
2023-04-25
Last updated
2026-01-23

Locations

16 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05827614. Inclusion in this directory is not an endorsement.