A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.
Population 1: Pathologically confirmed ER and/or PR positive, locoregionally recurrent or metastatic breast cancer that is refractory to endocrine therapy (progression on at least one line of endocrine therapy and determined by the investigator that Study Participant would not benefit from additional endocrine therapy) who have received at least one line of chemotherapy or antibody drug conjugate in the metastatic setting (recurrence within 6 months of adjuvant chemotherapy counts as one line of therapy). There is no limit on prior number of lines of endocrine therapy. Prior treatment with CDK4/6, AKT, PI3K and/or mTOR inhibitors is permitted.
Population 2: Pathologically confirmed ER positive and HER2 negative locoregional or metastatic breast adenocarcinoma that is not amenable to resection, with progression on at least one line of prior endocrine therapy in the adjuvant or metastatic setting and starting next line of therapy that will include endocrine therapy, such as tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression.
Population 3: Study Participants with pathologically confirmed, estrogen and/or progesterone receptor (ER and/or PR) positive and HER2 negative breast adenocarcinoma who are ineligible for Population 1 or 2.
At least one target or non-target lesion per RECIST 1.1
Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
Sequential
68Ga-R10602 injection
Drug68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
Incidence of adverse events
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Incidence of Serious Adverse Events
Number of participants with serious adverse events
Incidence of Clinically Significant Lab Changes
Number of participants with clinically significant change in clinical laboratory parameters
Number and location of tumors identified by 68Ga-R10602 PET/CT
Number of tumors identified by 68Ga-PET/CT per participant
Number and location of tumors identified by 68Ga-R10602 PET/CT
Location of tumors identified by 68Ga-10602 PET/CT per participants
Number and location of tumors identified by 68Ga-R10602 PET/CT
SUV max of tumor lesions per participant
Number and location of tumors identified by 68Ga-R10602 PET/CT
Ratio of tumor SUV over reference regions SUV
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