Imaging performance of RAD101 in patients with suspected recurrent brain metastases

An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants with Suspected Recurrent Brain Metastases from Solid Tumors

This study is testing a new imaging method called RAD101 to see if it can help adults with suspected recurring brain tumors from different types of cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radiopharm Theranostics, Ltd (Industry-sponsored)
• Drugs / interventions: Radiation
• Locations: 3 sites (Hoffman Estates, Illinois and 2 other locations)
• Trial ID: NCT06777433 on ClinicalTrials.gov

What this trial studies

This Phase 2b study evaluates the imaging performance of RAD101 PET in adults with suspected recurrent brain metastases from solid tumors. Participants will undergo a 4-week screening period followed by a single dose of RAD101, after which they will receive a whole brain PET scan and high-resolution MRI. The study aims to enroll approximately 30 participants, ensuring a diverse representation of tumor types, including lung, breast, colon, kidney, and melanoma. Safety assessments will be conducted throughout the study, with follow-up imaging and data collection extending up to 6 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed history of advanced solid tumors and suspected recurrent brain metastases.

Not a fit: Patients without a history of solid tumors or those with confirmed brain metastases that do not meet the study criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of imaging for detecting recurrent brain metastases, leading to better patient management.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for brain metastases, but the specific use of RAD101 PET is novel.

Eligibility criteria

Inclusion Criteria:

1. Must be ≥ 18 years of age at the time of signing the informed consent.
2. 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.
3. Participant has undergone SRS for their brain metastases prior to study screening with pre-planning images available for submission to the centralized imaging reader as reference.
4. Participant has suspected but not confirmed recurrent brain metastases in at least 1 but not more than 5 lesions previously treated with SRS, based on gadolinium-enhanced volumetric MRI (MRI preferred, otherwise CT) within 6 weeks prior to Day 1, with post-SRS images available for submission to the centralized imaging reader as reference. In addition, each suspected lesion must meet the following criteria:

   1. 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
   2. Lesion does not meet complete response criteria or unequivocal progressive disease criteria 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6. Creatinine clearance ≥ 60 mL/min according to the Cockroft-Gault formula
7. Life expectancy ≥4 months
8. Participant is not scheduled to undergo a confirmatory biopsy to characterize MRI findings until after the Day 1 study procedures have been completed.
9. Female participants must meet either of the following criteria:

   1. 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.
   2. 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.
10. 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.

    Highly effective contraception methods include:
    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (i.e., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
    2. Female sterilization (have had bilateral surgical oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
    3. Male sterilization (at least 6 months prior to Screening). The vasectomized male partner should be the sole partner for that participant and the absence of sperm should be confirmed.
    4. Use of oral, injected, or implanted hormonal methods of contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that inhibit ovulation and have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking IMP. Acceptable contraception methods are further described in the protocol.
11. Willing and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF), and willing to comply with all study procedures.

Exclusion Criteria:

1. History of known additional malignancy that is progressing or requires treatment.
2. Brain surgery within 4 weeks before the screening MRI.
3. Whole brain Radiation Therapy (RT) or SRS within 6 weeks of Day 1
4. Baseline Fridericia-corrected QT interval (QTcF) \> 470 msec or history of congenital long QT syndrome
5. 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.
6. Participation in any other investigational trial from the time of informed consent signature to the end of the Imaging and Safety Follow-Up Period.
7. 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.

Where this trial is running

Hoffman Estates, Illinois and 2 other locations

• Ascension Illinois Oncology Research — Hoffman Estates, Illinois, United States (Recruiting)
• Goshen Center for Cancer Care — Goshen, Indiana, United States (Recruiting)
• BAMF Health — Grand Rapids, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Dimitris Voliotis, MD

Conditions Brain Metastases from Solid Tumors; Brain Metastases