A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

Purpose

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

Conditions

  • Locoregionally Recurrent Hormone-receptor Positive Breast Cancer
  • Metastatic Hormone Receptor Positive Breast Cancer

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.