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Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications - Trial NCT06299761

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.

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NCT06299761
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06299761
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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

Study Focus

Solid Tumor

BBI-825

Interventional

drug

Sponsor & Location

Boundless Bio

Santa Monica,Grand Rapids,San Antonio, United States of America

Timeline & Enrollment

Phase 1

Mar 28, 2024

Feb 01, 2027

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, unspecified
Carcinoma in situ, unspecified
Malignant neoplasm: Parametrium
Malignant neoplasm of other connective and soft tissue
Malignant neoplasm: Lip, unspecified, inner aspect

Data Source

ClinicalTrials.gov

NCT06299761

Non-Device Trial