A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects With Solid Tumors
Following informed consent, subjects undergo baseline evaluation and disease assessment.
PR610 is administered intravenously weekly.
In the absence of progressive disease or unacceptable toxicity, subjects may continue to
receive PR610. Intra-subject dose escalation (to no higher than the highest safe level) is
allowed in subjects who are not experiencing dose limiting toxicity. Disease assessment will
be repeated at week 6 and then every 8 weeks thereafter.
Pharmacokinetic (PK) assessment (PR610 and PR610E) will be performed in cycle one and two
for all subjects.
After determination of the MTD and the determination of the phase II dose, additional
subjects with NSCLC that is genetically resistant to reversible EGFR inhibitors will be
accrued into an expansion cohort.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the Maximum Tolerated Dose (MTD) of PR610 as a Weekly IV Infusion
The first cohort of three subjects will receive PR610 at Dose Level 1. Subsequent cohorts will receive PR610 at a dose levels determined as per dose escalation criteria. The MTD will be defined as the dose level at which one (1) or fewer subject in six exhibit DLT with the next highest dose level demonstrating two (2) or more of six (6) subjects with DLT (or for which more than ≥33% of subjects exhibit DLT if the cohort size exceeds 6 subjects).
3 weeks (1 cycle)
United States: Food and Drug Administration
|Scottsdale Healthcare||Scottsdale, Arizona 85251|
|South Texas Accelerated Research Therapeutics||San Antonio, Texas 78229|
|Robert H. Lurie Comprehensive Cancer Research Center||Chicago, Illinois 60611|