RECRUITING

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

Conditions

Brain Metastases From Solid Tumors Brain Metastases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-13

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06777433

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. Other primary tumor diagnoses may be approved on a case-by-case basis following discussion with the Sponsor. 3. 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. 4. 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: 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 in the medical opinion of the evaluating provider or as outlined in Appendix 5 (Section 10.5). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6. 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) 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. 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.	1. History of known additional malignancy that is progressing or requires treatment. 2. Brain surgery for the target lesion within 4 weeks before the screening MRI. 3. Whole brain Radiation Therapy (RT), SRT, 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 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. 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.

Inclusion Criteria

Exclusion 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. Other primary tumor diagnoses may be approved on a case-by-case basis following discussion with the Sponsor.
3. 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.
4. 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:
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 in the medical opinion of the evaluating provider or as outlined in Appendix 5 (Section 10.5).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6. 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)
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.
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.

1. History of known additional malignancy that is progressing or requires treatment.
2. Brain surgery for the target lesion within 4 weeks before the screening MRI.
3. Whole brain Radiation Therapy (RT), SRT, 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 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.
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.

Contacts and Locations

Study Contact

Dimitris Voliotis, MD

CONTACT

646-535-5017

dv@radiopharmtheranostics.com

Principal Investigator

Dimitris Voliotis, MD

STUDY_DIRECTOR

Radiopharm Theranostics

Study Locations (Sites)

Ascension Illinois Oncology Research

Hoffman Estates, Illinois, 60169

United States

Goshen Center for Cancer Care

Goshen, Indiana, 46526

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

BAMF Health

Grand Rapids, Michigan, 49503

United States

Collaborators and Investigators

Sponsor: Radiopharm Theranostics, Ltd

Dimitris Voliotis, MD, STUDY_DIRECTOR, Radiopharm Theranostics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12-13

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Brain Metastases

Additional Relevant MeSH Terms

Brain Metastases From Solid Tumors