NCT06299761

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

Name: Clinical Trial NCT06299761
Creator: Boundless Bio
Keywords: Solid Tumor, BBI-825, Phase 1, drug, clinical trial, United States of America

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

Boundless Bio·Phase 1·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Solid Tumor
Drug/Device/Intervention: BBI-825
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Boundless Bio
Location: Santa Monica,Grand Rapids,San Antonio, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Mar 28, 2024
End date: Feb 01, 2027
Enrollment: 42 participants

Primary outcome

Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825,Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825

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.

ICD-10 classifications

Malignant neoplasm: Connective and soft tissue, unspecifiedCarcinoma in situ, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissueMalignant neoplasm: Lip, unspecified, inner aspect

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06299761
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06299761 through Pure Global AI's free database. This Phase 1 trial is sponsored by Boundless Bio and is currently Recruiting. The study focuses on Solid Tumor. Target enrollment is 42 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.