An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-19

Study Completion Date

2020-05-27

Brief Summary

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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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Detailed Description

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Conditions

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Triple Negative Breast Cancer Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gedatolisb + PTK7-ADC

Group Type EXPERIMENTAL

Gedatolisib

Intervention Type 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.

PTK7-ADC

Intervention Type 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.

Interventions

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Gedatolisib

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.

Intervention Type DRUG

PTK7-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.

Intervention Type DRUG

Other Intervention Names

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PF-06647020

Eligibility Criteria

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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