NCT06299761

Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Boundless Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.

Detailed description

BBI-825 will be administered orally (PO) twice daily (BID) to subjects with 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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BBI-825	Oral RNR inhibitor

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2024-03-08
• Last updated: 2026-01-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study