NCT06745804

Study of 68Ga-R10602

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Radionetics Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locoregionally Recurrent Hormone-receptor Positive Breast Cancer
• Metastatic Hormone Receptor Positive Breast Cancer
• Hormone Receptor Positive Breast Adenocarcinoma

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-12-20
• Last updated: 2026-03-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study