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

Phase 1

Completed

• Conditions: Triple Negative Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: Gedatolisib; Drug: PTK7-ADC

• Registration Number: NCT03243331
• Lead Sponsor: Kathy Miller

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-09
• Study Start: 2018-01-19
• Primary Completion: 2020-05-27
• Study Completion: 2020-05-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Gedatolisb + PTK7-ADC	PTK7-ADC	-
Gedatolisb + PTK7-ADC	Gedatolisib	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment
Overall response rate in all enrolled subjects	through study completion i.e. up to 1 year	efficacy as determined by overall response rate
Efficacy in all enrolled subjects	18 weeks	efficacy as determined by clinical benefit at 18 weeks
Progression free survival in all enrolled subjects	through study completion i.e. up to 1 year	efficacy as determined by progression free survival

Trial Locations

Locations (1)

IU Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States