A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
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.
Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer
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.
Sequential
68Ga-R11228
Drug68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions
177Lu-R11228
Drug177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions
Incidence of adverse events [68Ga-R11228]
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Incidence of Serious Adverse Events [68Ga-R11228]
Number of participants with serious adverse events
Incidence of adverse events [177Lu-R11228]
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Incidence of Serious Adverse Events [177Lu-R11228]
Number of participants with serious adverse events
Image quality
68Ga-R11228 positron emission tomography (PET) image quality as assessed by a 5-point Likert scale
Absorbed dose coefficients [68Ga-R11228]
Absorbed dose coefficients (milliGray \[mGy\]/megabecquerel \[MBq\]) in organs.
Standardized uptake value in tumor lesions [68Ga-R11228]
Standard uptake value (SUV) in tumor lesions
Effective whole-body dose for 68Ga-R11228
Effective whole-body dose (millisievert \[mSv\]/MBq) for 68Ga-R11228
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