Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer
Summary
A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.
Detailed description
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.
Arms & interventions
- Drug68Ga-R10602 injection
68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
Outcome measures
Primary
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
Secondary
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 Day
Number and location of tumor lesions identified by 68Ga-R10602 PET/CT versus standard of care imaging
Time frame: 1 day
Image quality
Time frame: 1 day
Absorbed dose coefficients and total body effective dose
Time frame: 1 day
Absorbed dose coefficients and total body effective dose
Time frame: 1 Day
PK parameters
Time frame: 1 day
PK parameters
Time frame: 1 Day
PK parameters
Time frame: 1 Day
PK parameters
Time frame: 1 Day
Eligibility criteria
Study locations (6)
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Michigan Medicine
Ann Arbor, Michigan, 48109
MD Anderson Cancer Center
Houston, Texas, 77030
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 844112