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

NCT06299761 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BBI-825

Oral RNR inhibitor

Sponsors & Collaborators

  • Boundless Bio

    lead INDUSTRY

Principal Investigators

  • Robert Doebele, MD · Boundless Bio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2025-06-25
Completion
2025-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299761 on ClinicalTrials.gov