Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Gedatolisb will be intravenously administered on Day 1, Day 8 and Day 15 of every 21 day cycle at a dose of 110 mg or 180mg depending on cohort assignment.
PTK7-ADC will be administered on Day 1 of every 21 day cycle at a dose of 1.4mg/kg or 2.8 mg/kg depending on cohort assignment.
IU Simon Cancer Center
Indianapolis, Indiana, United States
Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported
Time frame: through study completion i.e. up to 1 year
Efficacy in all enrolled subjects
efficacy as determined by clinical benefit at 18 weeks
Time frame: 18 weeks
Overall response rate in all enrolled subjects
efficacy as determined by overall response rate
Time frame: through study completion i.e. up to 1 year
Progression free survival in all enrolled subjects
efficacy as determined by progression free survival
Time frame: through study completion i.e. up to 1 year
Pharmacodynamic determination of inhibition of PI3k signaling
Pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage inhibition between samples.
Time frame: Cycle 1 Day 15
Pharmacodynamic determination modulation of Wnt pathway
pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage change in expression between samples.
Time frame: Cycle 1 Day 15
Pharmacodynamic determination modulation of Wnt pathway
RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Cycle 1 Day 15