Triple Negative Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
Interventions
DRUGGedatolisib
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.
DRUGPTK7-ADC
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.
Sponsors
Kathy Miller
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study will enroll 3 patients to the cohort 1 dose level. If 0 of 3 patients experience a DLT, the study will proceed to cohort 2. If 1 patient experiences a DLT, 3 additional patients will be enrolled into cohort 1. If 1 of 6 patients experience a DLT, the study will proceed and 3 patients will be enrolled to the cohort 2 dose level. If 0 patients experience a DLT in cohort 2, the study will proceed to cohort 3. If 1 patient experiences a DLT at cohort 2, 3 additional patients will be enrolled into cohort 2. If the study proceeds to cohort 3, 3 patients will be enrolled at this dose level. If 0 patients experience a DLT, the study will enroll an additional 3 patients at the cohort 3 dose level to better define the safety profile. If 1 of 3 patients experiences a DLT at cohort 3, 3 additional patients will still be enrolled into cohort 3. If 1 of 6 patients experience a DLT, the study will complete.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic Triple-negative Breast Cancer * Willingness to undergo tumor biopsy * Patients must have received at least 1 prior chemotherapy regimen for metastatic disease
Exclusion criteria
* Previous treatment with mTOR inhibitor * Untreated brain metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0 | through study completion i.e. up to 1 year | safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in all enrolled subjects | 18 weeks | efficacy as determined by clinical benefit at 18 weeks |
| Overall response rate in all enrolled subjects | through study completion i.e. up to 1 year | efficacy as determined by overall response rate |
| Progression free survival in all enrolled subjects | through study completion i.e. up to 1 year | efficacy as determined by progression free survival |
| Pharmacodynamic determination of inhibition of PI3k signaling | Cycle 1 Day 15 | 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. |
| Pharmacodynamic determination modulation of Wnt pathway | Cycle 1 Day 15 | 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. |
Countries
United States
Outcome results
None listed