Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2024-12-10
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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68Ga-R10602 Imaging Optimization Portion (Cohort 1)
68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints.
68Ga-R10602 injection
68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
68Ga-R10602 Imaging Confirmation Portion (Cohort 2)
68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint.
68Ga-R10602 injection
68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
Interventions
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68Ga-R10602 injection
68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
Eligibility Criteria
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Inclusion Criteria
* 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.
2. At least one target or non-target lesion per RECIST 1.1
3. Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of child-bearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
1. Medically acceptable adequate contraception for sexually active females with child-bearing potential include: 1) surgical sterilization (such as tubal ligation or hysterectomy), 2) approved hormonal contraceptives, 3) barrier method (such as condom or diaphragm) used with a spermicide, or 4) intrauterine device (IUD).
2. Medically acceptable adequate contraception for sexually active males include: 1) surgical sterilization (such as vasectomy), 2) a condom used with a spermicide.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
5. Adequate hepatic function as defined below (within 28 days of dosing with 68Ga R10602):
1. Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present, and
2. Serum bilirubin: total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN).
6. Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute), determined within 28 days of dosing with 68Ga-R10602.
7. Able to understand and willing to sign an informed consent form (ICF).
Exclusion Criteria
2. Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
3. Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
4. 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.
5. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
6. Major active infection requiring antibiotics.
7. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
8. Acute illness within 14 days prior to dosing with 68Ga-R10602 unless mild in severity, as assessed by the Investigator.
9. Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.
18 Years
ALL
No
Sponsors
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Radionetics Oncology
INDUSTRY
Responsible Party
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Locations
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UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan Medicine
Ann Arbor, Michigan, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R10602-101
Identifier Type: -
Identifier Source: org_study_id
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