Spots Global Cancer Trial Database for Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications

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Trial Identification

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

Official Title: 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

Study ID: NCT06299761

Conditions

Solid Tumor

Interventions

BBI-825

Study Description

Brief 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.