This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Immunocytokine infusion
Honor Health Research Institute
Scottsdale, Arizona, United States
Start Midwest
Grand Rapids, Michigan, United States
Hackensack Meridian John Theurer Cancer Center
Hackensack, New Jersey, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
The MTD will be the highest tested dose of BPT567 at which protocol specified number of patients experience DLT or the MAD, highest administered dose in the absence of DLTs
Time frame: Duration of first cycle (28 Days) for each cohort evaluated
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Rate of subjects reporting adverse events or serious adverse events including abnormalities in safety laboratory results
Time frame: Through end of study (up to 2 years)
Pharmacokinetic parameter - Maximum Concentration (Cmax)
Maximum concentration of BPT567
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax)
Time to maximum concentration of BPT567
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2)
Terminal elimination half-life of BPT567
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last))
(AUC)0-last of BPT567
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Providence Cancer Institute
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf)
AUC0-inf of BPT567
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Anti-drug Antibody (ADA) Response to BPT567
Number of Participants With Anti-drug Antibody (ADA) Response to BPT567
Time frame: Predose and postdose at multiple timepoints up to end of treatment (up to 2 years)
Objective response rate (ORR)
Per RECIST V1.1
Time frame: Through study completion up to 2 years
Duration of response (DoR)
Per RECIST V1.1
Time frame: Through study completion up to 2 years
Disease Control Rate (DCR)
Per RECIST V1.1
Time frame: Through study completion up to 2 years
Progression Free Survival (PFS)
Per RECIST V1.1
Time frame: Through study completion up to 2 years