Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With A… (NCT07178938) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases
10 participantsStarted 2026-04-30
Plain-language summary
This trial will evaluate treatment for patients with solid tumors with active brain metastases. Patients will be treated with a theranostic or diagnostic agent. Theranostic agents are targeted radioactive drugs used to identify (diagnose) and to deliver therapy. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of each of the theranostic agents in patients who have solid tumors with active brain metastases. In the diagnostic phase, the main objective is to determine the proportion of patients showing target expression in the brain lesion after a single dose of diagnostic agent. In the therapeutic phase, the theranostic agent's efficacy will be determined by assessing the response rate in the brain, defined as intracranial response rate at 24 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient, or legal representative (if applicable), must be capable to understand the purpose of the study and have signed written Informed Consent Form (ICF) prior to beginning specific protocol procedures.
. Male or female patients ≥ 18 years of age at the time of signing ICF.
. Radiologically documented locally advanced unresectable or metastatic breast cancer (BC).
. Histologically confirmed HER2-positive (HER2\[+\]) breast cancer based on local testing on the most recent analyzed biopsy according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
. Untreated newly diagnosed or progressing brain metastasis (BM) after prior local therapy. Any number of brain lesions is acceptable as long as all the eligibility criteria are fulfilled.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Measurable disease according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, with at least one measurable brain lesion of ≥ 10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging (MRI).
. Patients may or may not have type I leptomeningeal disease (LMD) per European Association of Neuro-Oncology (EANO)- European Society for Molecular Oncology (ESMO) criteria.
. Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrollment.
Exclusion criteria
. Participation in another clinical trial, interventional or observational, until the Study's safety visit (participation in retrospective studies or data analysis is allowed).
. Treatment with approved or investigational cancer therapy within 14 days prior to initiation of study drug.
. Known history of invasive malignancy and other than the malignancy of interest within 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
. Known allergy or hypersensitivity reaction to any investigational medicinal products (diagnostic radioligand) or their incorporated substances.
. Major surgical procedure or significant traumatic injury within 14 days before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.
. Pregnant or breastfeeding females or patients not willing to apply highly effective contraception as defined in the protocol.
. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment.
. Has active or uncontrolled infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive hepatitis B core antibody \[HBcAb\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.