Study of 68Ga-R10602

NCT06745804 | Recruiting Phase 1 FDA Drug

• 1 other identifier: R10602-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

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

Keywords

Hormone Receptor Positive Breast Cancer; Endocrine resistant; Radioisotope

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade

  Day 1 to Day 7

• Incidence of Serious Adverse Events

  Number of participants with serious adverse events

  Day 1 to Day 7

• Incidence of Clinically Significant Lab Changes

  Number of participants with clinically significant change in clinical laboratory parameters

  Day 1 to Day 7

Secondary Outcomes (12)

• Number and location of tumors identified by 68Ga-R10602 PET/CT

  1 day

• Number and location of tumors identified by 68Ga-R10602 PET/CT

  1 Day

• Number and location of tumors identified by 68Ga-R10602 PET/CT

  1 Day

• Number and location of tumors identified by 68Ga-R10602 PET/CT

  1 Day

• Number and location of tumor lesions identified by 68Ga-R10602 PET/CT versus standard of care imaging

  1 day

Study Arms (2)

68Ga-R10602 Imaging Optimization Portion (Cohort 1)

OTHER

68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints.

Drug: 68Ga-R10602 injection

68Ga-R10602 Imaging Confirmation Portion (Cohort 2)

OTHER

68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint.

Drug: 68Ga-R10602 injection

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

68Ga-R10602 Imaging Confirmation Portion (Cohort 2); 68Ga-R10602 Imaging Optimization Portion (Cohort 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 investigator that Study Participant would not benefit from additional endocrine therapy) who have received at least one line of chemotherapy or antibody drug conjugate in the metastatic setting (recurrence within 6 months of adjuvant chemotherapy counts as one line of therapy). There is no limit on prior number of lines of endocrine therapy. Prior treatment with CDK4/6, AKT, PI3K and/or mTOR inhibitors is permitted.
• Population 2: Pathologically confirmed ER positive and HER2 negative locoregional or metastatic breast adenocarcinoma that is not amenable to resection, 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 endocrine therapy, such as tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression.
• Population 3: Study Participants with pathologically confirmed, estrogen and/or progesterone receptor (ER and/or PR) positive and HER2 negative breast adenocarcinoma who are ineligible for Population 1 or 2.
• At least one target or non-target lesion per RECIST 1.1
• Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of child-bearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
• Medically acceptable adequate contraception for sexually active females with child-bearing potential include: 1) surgical sterilization (such as tubal ligation or hysterectomy), 2) approved hormonal contraceptives, 3) barrier method (such as condom or diaphragm) used with a spermicide, or 4) intrauterine device (IUD).
• Medically acceptable adequate contraception for sexually active males include: 1) surgical sterilization (such as vasectomy), 2) a condom used with a spermicide.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
• Adequate hepatic function as defined below (within 28 days of dosing with 68Ga R10602):
• Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present, and
• Serum bilirubin: total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN).
• Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute), determined within 28 days of dosing with 68Ga-R10602.
• Able to understand and willing to sign an informed consent form (ICF).

You may not qualify if:

• Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
• Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
• Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
• 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.
• History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
• Major active infection requiring antibiotics.
• Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
• Acute illness within 14 days prior to dosing with 68Ga-R10602 unless mild in severity, as assessed by the Investigator.
• 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.

Sponsors & Collaborators

• Radionetics Oncology: lead

Study Sites (6)

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, 90095, United States

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 844112, United States

RECRUITING

Central Study Contacts

Yael Cohen-Arazi

CONTACT

858-218-6617; R10602-101@radionetics.com

Kristrun Stardal

CONTACT

858-218-6617; R10602-101@radionetics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)