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

NCT ID: NCT06299761

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2025-06-25

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Agent Dose Escalation

Single agent BBI-825, administered orally, twice daily, in 28-day cycles

Group Type: EXPERIMENTAL

BBI-825

Intervention Type: DRUG

Oral RNR inhibitor

Interventions

BBI-825

Oral RNR inhibitor

Intervention Type: DRUG

Other Intervention Names

ribonucleotide reductase inhibitor

Eligibility Criteria

Inclusion Criteria

• 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,
• Availability of FFPE tumor tissue, archival or newly obtained,
• Measurable disease as defined by RECIST Version 1.1,
• Adequate hematologic function,
• Adequate hepatic and renal function,
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,

Exclusion Criteria

• Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted),
• Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives,
• Hematologic malignancies,
• Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
• Prior or concurrent malignancies, with exceptions per study protocol,
• History of HBV, HCV, or HIV infection,
• Clinically significant cardiac condition,
• Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
• QTcF > 470 msec,
• Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boundless Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Doebele, MD

Role: STUDY_DIRECTOR

Boundless Bio

Locations

Sarcoma Oncology Research Center

Santa Monica, California, United States

START Midwest

Grand Rapids, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NEXT Oncology

Irving, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Countries

United States

Other Identifiers

BBI-825-101

Identifier Type: -

Identifier Source: org_study_id