Imaging study using 68Ga-R10602 for hormone-receptor positive breast cancer

Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer

This study is testing a new imaging agent to see if it can safely help track hormone-receptor positive breast cancer that hasn't responded to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radionetics Oncology (industry)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Los Angeles, California and 5 other locations)
• Trial ID: NCT06745804 on ClinicalTrials.gov

What this trial studies

This phase 1 study evaluates the safety and imaging effectiveness of 68Ga-R10602 in patients with hormone-receptor positive breast cancer that is either locoregionally recurrent or metastatic and has shown resistance to endocrine therapy. The study includes two patient populations: one with endocrine-resistant breast cancer who have undergone chemotherapy, and another with non-resectable breast adenocarcinoma progressing on prior endocrine therapy. Participants will receive a single dose of the radioisotope, followed by imaging and blood dosimetry at specified timepoints to assess the drug's distribution and effectiveness.

Who should consider this trial

Good fit: Ideal candidates include patients with locoregionally recurrent or metastatic hormone-receptor positive breast cancer that is resistant to endocrine therapy.

Not a fit: Patients with hormone-receptor negative breast cancer or those who have not progressed on prior endocrine therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new imaging method to better understand and treat hormone-receptor positive breast cancer.

How similar studies have performed: Other studies using radioisotopes for imaging in cancer have shown promise, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Breast Cancer Eligibility:

   * 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:

1. Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
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.

Where this trial is running

Los Angeles, California and 5 other locations

• UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States (RECRUITING)
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (RECRUITING)
• University of Iowa — Iowa City, Iowa, United States (RECRUITING)
• University of Michigan Medicine — Ann Arbor, Michigan, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Yael Cohen-Arazi

Conditions: Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer, Hormone Receptor Positive Breast Adenocarcinoma, Hormone Receptor Positive Breast Cancer, Endocrine resistant, Radioisotope