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

NCT03243331 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IUSCC-0613
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer

Conditions

Triple Negative Breast Cancer; Metastatic Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Efficacy in all enrolled subjects

  18 weeks

• Overall response rate in all enrolled subjects

  through study completion i.e. up to 1 year

• Progression free survival in all enrolled subjects

  through study completion i.e. up to 1 year

• Pharmacodynamic determination of inhibition of PI3k signaling

  Cycle 1 Day 15

• Pharmacodynamic determination modulation of Wnt pathway

  Cycle 1 Day 15

Study Arms (1)

Gedatolisb + PTK7-ADC

EXPERIMENTAL

Drug: Gedatolisib; Drug: PTK7-ADC

Interventions

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.

Gedatolisb + PTK7-ADC

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.

Also known as: PF-06647020

Gedatolisb + PTK7-ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic Triple-negative Breast Cancer
• Willingness to undergo tumor biopsy
• Patients must have received at least 1 prior chemotherapy regimen for metastatic disease

You may not qualify if:

• Previous treatment with mTOR inhibitor
• Untreated brain metastases

Sponsors & Collaborators

• Kathy Miller: lead

Study Sites (1)

IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

gedatolisib; cofetuzumab pelidotin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kathy Miller, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Milan Radovich, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 9, 2017
• Study Start: January 19, 2018
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

US (1)