68Ga-R11228 PET imaging and 177Lu-R11228 targeted radiotherapy for hormone-receptor positive breast cancer
Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer
This test uses a PET imaging agent (68Ga-R11228) to find ER+/PR+ HER2− breast cancer lesions and, for people with positive scans, gives a matching radioligand therapy (177Lu-R11228) to try to treat them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radionetics Oncology Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Indianapolis, Indiana and 6 other locations) |
| Trial ID | NCT07121244 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study first gives single doses of the PET agent 68Ga-R11228 (Part A) to determine safe dosing and how well it visualizes ER/PR+ HER2− recurrent or metastatic breast cancer lesions. In Part B, patients with PET-positive lesions may receive multiple doses of the therapeutic radioligand 177Lu-R11228 over about 36 weeks with dose escalation to define safety and tolerability. Part B requires endocrine-refractory disease and prior or declined chemotherapy/antibody-drug conjugate in the metastatic setting. A long-term follow-up period of up to 5 years begins after completion of the last 177Lu-R11228 dose.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed ER and/or PR positive, HER2-negative locoregionally recurrent or metastatic breast cancer are eligible for Part A, and Part B is for those with endocrine-refractory disease who have at least one PET-positive lesion and have received or declined prior chemotherapy/ADC.
Not a fit: Patients whose tumors do not take up the 68Ga-R11228 tracer on PET, those with HER2-positive disease, pregnant or breastfeeding individuals, or patients with early-stage non-metastatic disease are unlikely to benefit from the investigational therapy.
Why it matters
Potential benefit: If successful, this approach could enable more precise detection and deliver targeted radioligand therapy to shrink tumors while limiting exposure to normal tissues in endocrine-resistant HR+ breast cancer.
How similar studies have performed: Radioligand therapies using 177Lu have shown meaningful results in other cancers (for example PSMA-targeted prostate cancer), but using 68Ga/177Lu agents specifically in hormone-receptor positive breast cancer is a novel application with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Part A * Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer * At least one target or non-target lesion per RECIST v1.1 criteria. * Male or non-pregnant, non-lactating female subjects age ≥18 years. Part B * Pathologically confirmed estrogen and/or progesterone receptor (ER/PR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer * Refractory to endocrine therapy. Note: there is no limit on prior number of lines of endocrine therapy or prior treatments with CDK4/6, AKT, PI3K and/or mTOR inhibitors. * Received or declined at least one line of chemotherapy or antibody drug conjugate in the locoregionally recurrent or metastatic setting * Progressive disease or intolerance to last treatment. * At least one target lesion per RECIST v1.1 criteria. * Male or non-pregnant, non-lactating female subjects age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Life expectancy of at least six months. * Adequate bone marrow reserve, hepatic function and renal function. Exclusion Criteria: Part A * Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention. * Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period. * Radiotherapy for breast cancer ≤ 28 days prior * Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228. * Any condition that precludes the proper performance of imaging procedures required in this study. Part B * Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy/intervention * Treatment with anticancer therapy or with an investigational drug or device within 21 days or 5 half-lives of the agent (whichever is shorter) * Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period. * Radiotherapy for breast cancer ≤ 28 days * Prior systemic radionuclide therapeutic treatment. * Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228. * Any unresolved NCI-CTCAE Version 5.0 Grade 2 or higher toxicity (except alopecia and Grade 2 platinum-therapy related neuropathy) from previous breast cancer treatment and/or from medical/surgical procedures or interventions. * Any condition that precludes the proper performance of imaging procedures required in this study.
Where this trial is running
Indianapolis, Indiana and 6 other locations
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- United Theranostics — Glen Burnie, Maryland, United States (Recruiting)
- United Theranostics Princeton — Princeton, New Jersey, United States (Recruiting)
- University Hospital Seidman Cancer Center — Cleveland, Ohio, 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)
- Melbourne Theranostic Innovation Centre (MTIC) — Melbourne, Australia (Recruiting)
Study contacts
- Study coordinator: Kristrun Stardal
- Email: kstardal@radionetics.com
- Phone: 8582186617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.