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Completed

NCT Number: NCT03243331

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

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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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: PF-06647020

Primary outcomes

  1. Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0

    Time frame: 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 outcomes

  1. Efficacy in all enrolled subjects

    Time frame: 18 weeks

    efficacy as determined by clinical benefit at 18 weeks

  2. Overall response rate in all enrolled subjects

    Time frame: through study completion i.e. up to 1 year

    efficacy as determined by overall response rate

  3. Progression free survival in all enrolled subjects

    Time frame: through study completion i.e. up to 1 year

    efficacy as determined by progression free survival

  4. Pharmacodynamic determination of inhibition of PI3k signaling

    Time frame: 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.

  5. Pharmacodynamic determination modulation of Wnt pathway

    Time frame: 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 change in expression between samples.

  6. Pharmacodynamic determination modulation of Wnt pathway

    Time frame: Cycle 1 Day 15

    RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment

Sponsors and collaborators

Lead sponsor

Kathy Miller

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2017
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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