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Trial Title:
Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications
NCT ID:
NCT06299761
Condition:
Solid Tumor
Conditions: Keywords:
Amplification
Oncogene Amplification
ribonucleotide reductase inhibitor
RNR inhibitor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
BBI-825 single agent dose escalation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BBI-825
Description:
Oral RNR inhibitor
Arm group label:
Single Agent Dose Escalation
Other name:
ribonucleotide reductase inhibitor
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.
Criteria for 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,
- Other inclusion criteria per study protocol.
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,
- Other exclusion criteria per study protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarcoma Oncology Research Center
Address:
City:
Santa Monica
Zip:
90403
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Start date:
March 28, 2024
Completion date:
February 2027
Lead sponsor:
Agency:
Boundless Bio
Agency class:
Industry
Source:
Boundless Bio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06299761
