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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Oral RNR inhibitor
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
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825
TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825
The MTD and/or RP2D of BBI-825 will be determined.
Time frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
Maximum observed plasma concentration (Cmax) of BBI-825
Maximum observed plasma concentration (Cmax) of BBI-825 will be determined.
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Trough observed plasma concentration (Ctrough) of BBI-825
Trough observed plasma concentration (Ctrough) of BBI-825 will be determined.
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Time to Cmax (Tmax) of BBI-825
Time to Cmax (Tmax) of BBI-825 will be determined.
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Area under the concentration time curve (AUC) of BBI-825
Area under the concentration time curve (AUC) of BBI-825 will be determined.
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Anti-tumor activity of BBI-825 as determined by RECISTv1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NEXT Oncology
San Antonio, Texas, United States
Number of participants achieving a best response of progressive disease, stable disease, partial response, or complete response.
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)