Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 treatments with CDK4/6, AKT, PI3K and/or mTOR inhibitors. - Received or declined at least one line of chemotherapy or antibody drug conjugate in the locoregionally recurrent or metastatic setting - Progressive disease or intolerance to last treatment. - At least one target lesion per RECIST v1.1 criteria. - Male or non-pregnant, non-lactating female subjects age ≥18 years. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Life expectancy of at least six months. - Adequate bone marrow reserve, hepatic function and renal function.

Exclusion Criteria

Part A - Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention. - Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period. - Radiotherapy for breast cancer ≤ 28 days prior - Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228. - Any condition that precludes the proper performance of imaging procedures required in this study. Part B - Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention - Treatment with anticancer therapy or with an investigational drug or device within 21 days or 5 half-lives of the agent (whichever is shorter) - Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period. - Radiotherapy for breast cancer ≤ 28 days - Prior systemic radionuclide therapeutic treatment. - Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228. - Any unresolved NCI-CTCAE Version 5.0 Grade 2 or higher toxicity (except alopecia and Grade 2 platinum-therapy related neuropathy) from previous breast cancer treatment and/or from medical/surgical procedures or interventions. - Any condition that precludes the proper performance of imaging procedures required in this study.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: 68Ga-R11228 Dose Optimization Portion
68Ga-R11228 injection at pre-defined dose levels.
  • Drug: 68Ga-R11228
    68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
Experimental
Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion
68Ga-R11228 injection at pre-defined dose. 177Lu-R11228 injection at pre-defined doses.
  • 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

Recruiting Locations

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Xin Bryan
317 274 5495
zhongx@iu.edu

United Theranostics
Glen Burnie, Maryland 21061
Contact:
Amanda Huggins
667-HOPENOW
clinicaltrial@unithera.com

United Theranostics Princeton
Princeton, New Jersey 08540
Contact:
Amanda Huggins
667-HOPENOW
clinicaltrial@unithera.com

University Hospital Seidman Cancer Center
Cleveland, Ohio 44106
Contact:
Alberto Montero
(216) 844-3951
Alberto.Montero@UHhospitals.org

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Nathan Comeaux
NIComeaux@mdanderson.org

University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah 84112
Contact:
Blake Nordblad
blake.nordblad@hci.utah.edu

More Details

Status
Recruiting
Sponsor
Radionetics Oncology

Study Contact

Kristrun Stardal
8582186617
kstardal@radionetics.com

Detailed 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 using 68Ga-R11228. Patients who qualify for 177Lu-R11228 treatment will receive up to 6 doses over approximately 36 weeks. Multiple 177Lu-R11228 dose levels will be evaluated in Part B. A 5-year Follow-Up Period begins once the last cycle of 177Lu-R11228 dosing is completed.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.