Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases

NCT06777433 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: GCP-PRT-101-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

This is an open-label, single dose, single arm, multicenter Phase 2b study to establish the imaging performance of RAD101 PET in participants who are ≥ 18 years of age and with suspected recurrent brain metastases from solid tumors. The study consists of a 4-week Screening Period, a 3-day Imaging and Safety Follow-Up Period, and a Data Collection Period of up to 6 months. Participant eligibility will be determined during the Screening Period and eligible participants will be enrolled in the study. On Day 1, the enrolled participants will receive a single dose of the investigational medicinal product (IMP), RAD101. Participants will then proceed with a whole brain PET scan. A high-resolution Magnetic Resonance Imaging (MRI) will be performed in joint acquisition with PET or separately on the same day, or on the day prior to or the day following RAD101 administration. For applicable study sites where PK samples will be collected, whole body PET scans will be performed, blood samples will be drawn, and urine will be collected throughout the scanning period. A phone follow-up will be performed on Day 3 (+ 1 day). Participants will have follow-up (longitudinal) MRI (otherwise CT) scans (longitudinal imaging) and/ or a biopsy according to their Standard of Care (SoC). The longitudinal image results, and details of the biopsy if performed as part of SoC (i.e., location and histopathology results), will be collected during the 6- month Data Collection Period.

Conditions

Brain Metastases From Solid Tumors

Keywords

Brain Metastases

Outcome Measures

Primary Outcomes (3)

• Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium

  Number, size, and proportion of SRS/SRT-treated lesions identified by both RAD101 PET/MRI and MRI (with macrocyclic gadolinium)

  1 Week

• Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium

  Number, size, and proportion of SRS/SRT-treated lesions identified by RAD101 PET/MRI and not identified by MRI (with macrocyclic gadolinium)

  1 Week

• Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium

  Number, size, and proportion of SRS/SRT-treated lesions not identified by RAD101 PET/MRI and identified by MRI (with macrocyclic gadolinium)

  1 Week

Secondary Outcomes (7)

• Accuracy of RAD101 in identifying tumor recurrence versus radiation necrosis in previously SRS-treated brain metastasis

  6 months

• Safety and tolerability of a single dose of RAD101

  48 Hours

• Optimal dose of RAD101

  1 week

• Performance of RAD101 PET in identifying tumor lesions

  1 week

• Performance of RAD101 PET in identifying tumor lesions

  1 week

Study Arms (1)

RAD101 (18F-Fluorescence polarization immunoassay (FPIA))

EXPERIMENTAL

370 MBq (10 mCi) single dose administered at Day 1 visit

Drug: RAD101 (18F-FPIA)

Interventions

RAD101 (18F-FPIA) DRUG

A single dose of 18F-RAD101 with a maximum of 370 MBq (10 mCi) administered as a slow IV bolus injection over a maximum of 30 seconds, followed by a saline flush.

RAD101 (18F-Fluorescence polarization immunoassay (FPIA))

Eligibility Criteria

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

You may qualify if:

• Must be ≥ 18 years of age at the time of signing the informed consent.
• Participant has one of the following histopathologically confirmed advanced solid tumors with known history of brain metastases: lung, breast, colon, kidney, or melanoma, and with known history of brain metastases. Other primary tumor diagnoses may be approved on a case-by-case basis following discussion with the Sponsor.
• Participant has undergone SRS or SRT for their brain metastases prior to study screening with pre-planning images available for submission to the centralized imaging reader as reference.
• Participant has suspected but not confirmed recurrent brain metastases in at least 1 lesion previously treated with SRS or SRT, based on gadolinium-enhanced volumetric MRI (MRI preferred, otherwise CT) within 8 weeks prior to Day 1, with post-SRS/SRT images available for submission to the centralized imaging reader as reference. If the SoC scan was performed \> 8 weeks before Day 1, discussion with the Sponsor is required to determine eligibility. In addition, each suspected lesion must meet the following criteria:
• Size must be at least 5 mm in longest diameter seen on 2 slices on the volumetric MRI analyzed at 2.5 mm slice thickness, AND
• Lesion does not meet complete response criteria or unequivocal progressive disease criteria in the medical opinion of the evaluating provider or as outlined in Appendix 5 (Section 10.5).
• Note: New brain metastases or new leptomeningeal disease based on macrocyclic gadolinium-enhanced MRI within 6 weeks prior to Day 1, in addition to the above findings, are permitted.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and individualized for participant's body surface area (BSA) ≥ 45 ml/min (ie, nonindexed GFR = indexed GFR × BSA (m2)/1.73 m2)
• Life expectancy ≥4 months
• Participant is not scheduled to undergo a confirmatory biopsy to characterize MRI findings until after the Day 1 study procedures have been completed.
• Female participants must meet either of the following criteria:
• Women of childbearing potential (WOCBP) must have a negative beta human chorionic gonadotropin (β-hCG) test within 72 hours before administration of IMP and must not be breastfeeding. WOCBP, defined as all women physiologically capable of becoming pregnant, should agree to use highly effective methods of contraception during dosing and for 12 hours after administration of RAD101.
• Women who are not of childbearing potential are those who are surgically sterile or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
• Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during dosing and for 12 hours after administration of IMP. All male participants must agree to not donate sperm for 12 hours after administration of IMP.

You may not qualify if:

• History of known additional malignancy that is progressing or requires treatment.
• Brain surgery for the target lesion within 4 weeks before the screening MRI.
• Whole brain Radiation Therapy (RT), SRT, or SRS within 6 weeks of Day 1
• Baseline Fridericia-corrected QT interval (QTcF) \> 470 msec or history of congenital long QT syndrome
• Any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures, such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, and participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures.
• Participation in any other investigational trial from the time of informed consent signature to the end of the Imaging and Safety Follow-Up Period if participation in the other study would interfere with the current study or would not be allowed by the other study. Participation in another study should be discussed with the Sponsor.
• History of uncontrolled allergic reactions and/or known or expected hypersensitivity to RAD101, or any of its excipients, and/or macrocyclic gadolinium-based contrast agents.

Sponsors & Collaborators

• Radiopharm Theranostics, Ltd: lead
• Medpace, Inc.: collaborator

Study Sites (5)

Ascension Illinois Oncology Research

Hoffman Estates, Illinois, 60169, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dimitris Voliotis, MD

  Radiopharm Theranostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 15, 2025
• Study Start: December 13, 2024
• Primary Completion: April 23, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)