Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06745804

Study of 68Ga-R10602

Led by Radionetics Oncology · Updated on 2026-03-13

36

Participants Needed

6

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Study of 68Ga-R10602

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed ER and/or PR positive, locoregionally recurrent or metastatic breast cancer refractory to endocrine therapy with at least one prior line of chemotherapy or antibody drug conjugate for Population 1
  • ER positive and HER2 negative locoregional or metastatic breast adenocarcinoma progressing on at least one line of prior endocrine therapy and starting next endocrine therapy for Population 2
  • ER and/or PR positive and HER2 negative breast adenocarcinoma for Population 3 if ineligible for Populations 1 or 2
  • At least one target or non-target lesion per RECIST 1.1
  • Male or non-pregnant, non-lactating female aged 18 years or older
  • Female of child-bearing potential and sexually active male must agree to use effective contraception during the study
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
  • Adequate liver function within 28 days before dosing
  • Adequate renal function (creatinine clearance ≥60 mL/min) within 28 days before dosing
  • Able to understand and sign informed consent form
Not Eligible

You will not qualify if you...

  • Received radionuclide within less than 10 physical half-lives before dosing
  • Radiotherapy within 14 days before dosing
  • Major surgery within 21 days before dosing or not recovered from surgery effects
  • Severe or unstable medical conditions such as advanced heart failure, ischemic heart disease, uncontrolled hypertension or diabetes, significant cardiac arrhythmia, recent myocardial infarction, or other unstable cardiac illness
  • History of cerebrovascular accident within 6 months or ongoing neurologic instability
  • Major active infection requiring antibiotics
  • Known active HIV infection or active Hepatitis B or C infection
  • Acute illness within 14 days before dosing unless mild
  • Any other condition that poses unacceptable risk or limits study participation or compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, United States, 90095

Actively Recruiting

2

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

3

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

4

University of Michigan Medicine

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

5

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

6

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States, 844112

Actively Recruiting

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Research Team

Y

Yael Cohen-Arazi

CONTACT

K

Kristrun Stardal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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