This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.
This first-in-human study of SBP-101 will be conducted in two phases: dose escalation and expansion. The dose escalation phase of the study is to evaluate the safety, tolerability and PK profile of SBP-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. Up to 48 subjects may be enrolled in dose escalation. The expansion phase of the study will consist of 24 additional subjects who will receive the maximum tolerated dose of SBP-101 based on data from the dose escalation phase of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Subcutaneous drug, escalating dose cohorts
HonorHealth Research Institute
Scottsdale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Ashford Cancer Centre
Kurralta Park, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Maximum tolerated dose of SBP-101
Time frame: Up to 18 months following the first dose of treatment
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: Up to 30 months following the first dose of treatment
Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions
Time frame: Every 8 weeks during treatment assessed up to 30 months
Area under the plasma concentration versus time curve (AUC)
Time frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Peak plasma concentration (Cmax)
Time frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Plasma drug half-life
Time frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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