Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer

Radionetics Oncology

Summary

A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.

Description

Patients with metastatic or locoregionally recurrent ER+ and/or PR+ and HER2 negative breast cancer will be enrolled. Part A is being conducted to test 68Ga-R11228, a new investigational product (IP) that has been designed to detect cancer lesions in the body and make them visible on a Positron Emission Tomography (PET) scan. Three dose levels of 68Ga-R11228 will be evaluated, with each patient receiving a single dose. Part B is being conducted to test 68Ga-R11228 and additionally 177Lu-R11228, which has been designed to treat patients who have cancer lesions with positive uptake on PET scan…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: Part A * Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer * At least one target or non-target lesion per RECIST v1.1 criteria. * Male or non-pregnant, non-lactating female subjects age ≥18 years. Part B * Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer * Refractory to endocrine therapy. Note: there is no limit on prior number of lines of endocrine therapy or prior trea…

Interventions

Drug
68Ga-R11228
68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
Drug
177Lu-R11228
177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions

Locations (7)

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana
zhongx@iu.edu 317 274 5495
United Theranostics
Glen Burnie, Maryland
clinicaltrial@unithera.com 667-HOPENOW
United Theranostics Princeton
Princeton, New Jersey
clinicaltrial@unithera.com 667-HOPENOW
University Hospital Seidman Cancer Center
Cleveland, Ohio
Alberto.Montero@UHhospitals.org (216) 844-3951
MD Anderson Cancer Center
Houston, Texas
NIComeaux@mdanderson.org
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah
blake.nordblad@hci.utah.edu