MedTrace Logo

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

NCT03243331 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-01-07

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Kathy Miller

    lead OTHER

Principal Investigators

  • Kathy Miller, MD · Indiana University

  • Milan Radovich, PhD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2020-05-27
Completion
2020-05-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243331 on ClinicalTrials.gov