A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.
There are three eligible disease populations for the study. Population 1 are patients with metastatic or locoregionally recurrent, endocrine-resistant, ER+ and/or PR+ breast cancer who have received at least one line of chemotherapy or ADC. Population 2 are patients with ER+ and HER2- locoregional or metastatic non-resectable breast adenocarcinoma 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 tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression. Population 3 are patients with ER+ and/or PR+ and HER2- breast cancer who are ineligible for Population 1 or 2. All disease populations are eligible for both cohorts. Cohort 1 will consist of three dose de-escalating cohorts with four patients each for a total of twelve patients. Once the twelve patients have completed the dose de-escalation, the three dose levels will be evaluated, and additional subjects may be enrolled into Cohort 1 at the single chosen dose. All patients will undergo imaging at a single timepoint and no dosimetry will be performed. In Cohort 2, approximately six to eight patients will receive the single chosen dose followed by imaging at five timepoints and blood dosimetry at seven timepoints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
36
68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
RECRUITINGIndiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
Incidence of adverse events
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Time frame: Day 1 to Day 7
Incidence of Serious Adverse Events
Number of participants with serious adverse events
Time frame: Day 1 to Day 7
Incidence of Clinically Significant Lab Changes
Number of participants with clinically significant change in clinical laboratory parameters
Time frame: Day 1 to Day 7
Number and location of tumors identified by 68Ga-R10602 PET/CT
Number of tumors identified by 68Ga-PET/CT per participant
Time frame: 1 day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Location of tumors identified by 68Ga-10602 PET/CT per participants
Time frame: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
SUV max of tumor lesions per participant
Time frame: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Ratio of tumor SUV over reference regions SUV
Time frame: 1 Day
Number and location of tumor lesions identified by 68Ga-R10602 PET/CT versus standard of care imaging
Number and location of tumor lesions identified by 68Ga-R10602 PET/CT and by standard of care imaging (e.g. contrast enhanced diagnostic CT) and concordance rate between 68Ga-R10602 PET/CT and standard of care images.
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University of Michigan Medicine
Ann Arbor, Michigan, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGUniversity of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
RECRUITINGTime frame: 1 day
Image quality
Image quality as assessed by a 5-point Likert scale by central review
Time frame: 1 day
Absorbed dose coefficients and total body effective dose
Absorbed dose coefficients (milliGray \[mGy\]/megabecquerel \[MBq\]) in organs.
Time frame: 1 day
Absorbed dose coefficients and total body effective dose
The total body effective dose (milliSievert \[mSv\]/MBq).
Time frame: 1 Day
PK parameters
PK parameters, including Cmax
Time frame: 1 day
PK parameters
PK parameters including area under the curve (AUC).
Time frame: 1 Day
PK parameters
PK parameters including half-life (T1/2) in blood samples.
Time frame: 1 Day
PK parameters
Other pharmacokinetic (PK) parameters may also be evaluated as needed to support the outcome measure.
Time frame: 1 Day