Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
68Ga-R10602 · 1 trial · 3 indications
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Number of participants with serious adverse events
Number of participants with clinically significant change in clinical laboratory parameters
| Arm | Type | Description |
|---|---|---|
| 68Ga-R10602 Imaging Optimization Portion (Cohort 1) | OTHER | 68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints. |
| 68Ga-R10602 Imaging Confirmation Portion (Cohort 2) | OTHER | 68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint. |
| Name | Type | Description |
|---|---|---|
| 68Ga-R10602 injection | DRUG | 68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer |
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 investigato...