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Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gedatolisb + PTK7-ADC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gedatolisib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion i.e. up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in all enrolled subjects | efficacy as determined by clinical benefit at 18 weeks | 18 weeks |
| Overall response rate in all enrolled subjects | efficacy as determined by overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Miller, MD | Indiana University | Principal Investigator |
| Milan Radovich, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C549060 | gedatolisib |
| C000723554 | cofetuzumab pelidotin |
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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.
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| PTK7-ADC | Drug | 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. |
|
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| through study completion i.e. up to 1 year |
| Progression free survival in all enrolled subjects | efficacy as determined by progression free survival | 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. | 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. | 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 | Cycle 1 Day 15 |
| D017437 |
| Skin and Connective Tissue Diseases |