Study of 68Ga-R10602

Part of paid clinical trials in Los Angeles, California.

Sponsor
Radionetics Oncology
Study ID
NCT06745804
Phase
PHASE1
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.

Key Dates

Start date
Dec 10, 2024
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Other: 68Ga-R10602 Imaging Optimization Portion (Cohort 1)
    68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints.
  • Other: 68Ga-R10602 Imaging Confirmation Portion (Cohort 2)
    68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Day 1 to Day 7 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA Department of Medicine - Hematology/OncologyLos AngelesCalifornia90095
Bhavisha Tailor
424-402-9520
Nicolaos Palaskas, MD, PhD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202
Xin Bryan
317-274-5495
Kathy Miller, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Shannon Lehman
319-356-2259
Parren McNeely, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan MedicineAnn ArborMichigan48109
James Pool
734-615-9016
Benjamin Viglianti, MD
734-615-9016
Benjamin Viglianti, MD (PRINCIPAL_INVESTIGATOR)
Monika Burness, MD (SUB_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Edsel Esquivel
832-794-1665
Jorge Bellido
713-501-0379
Sanjit Tewari, MD (PRINCIPAL_INVESTIGATOR)
Ajit Bisen, MD (SUB_INVESTIGATOR)
University of Utah, Huntsman Cancer InstituteSalt Lake CityUtah844112
Sam Mitchell
801-213-6110
Jeffrey Yap, PhD (PRINCIPAL_INVESTIGATOR)

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