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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: 68Ga-R11228 Dose Optimization Portion |
68Ga-R11228 injection at pre-defined dose levels. |
|
|
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. |
|
Recruiting Locations
Indianapolis, Indiana 46202
Glen Burnie, Maryland 21061
Princeton, New Jersey 08540
Cleveland, Ohio 44106
Salt Lake City, Utah 84112
More Details
- Status
- Recruiting
- Sponsor
- Radionetics Oncology
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.