Study of 68Ga-R10602

Description

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

Conditions

Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer

Study Overview

Study Details

Study overview

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

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

Study of 68Ga-R10602

Condition
Locoregionally Recurrent Hormone-receptor Positive Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Breast Cancer Eligibility:
  • 2. At least one measurable target lesion per RECIST 1.1 criteria within 42 days of dosing with 68Ga-R10602.
  • 3. Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of childbearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
  • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
  • 5. Adequate hepatic function (within 28 days of dosing with 68Ga-R10602)
  • 6. Adequate renal function determined within 28 days of dosing with 68GaR10602.
  • 7. Able to understand and willing to sign an informed consent form.
  • 1. Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
  • 2. Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
  • 3. Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
  • 4. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE, Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
  • 5. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
  • 6. Major active infection requiring antibiotics.
  • 7. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
  • 8. Acute illness within 14 days prior to dosing with 68GaR10602 unless mild in severity, as assessed by the Investigator.
  • 9. Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Radionetics Oncology,

Study Record Dates

2025-12