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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243331
• Other study ID #: IUSCC-0613
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2018
• Est. completion date: May 27, 2020

Study information

• Verified date: January 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	IU Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Kathy Miller

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy in all enrolled subjects	efficacy as determined by clinical benefit at 18 weeks	18 weeks
Secondary	Overall response rate in all enrolled subjects	efficacy as determined by overall response rate	through study completion i.e. up to 1 year
Secondary	Progression free survival in all enrolled subjects	efficacy as determined by progression free survival	through study completion i.e. up to 1 year
Secondary	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
Secondary	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
Secondary	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