Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedSIR
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)
DrugPatients will receive a single infusion of the diagnostic agent \[68Ga\]Ga-DOTA-TOC will which will be detected by Positron Emission Tomography/Computed Tomography (PET/CT) imaging. The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection and for a single use only.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Arm AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients showing target expression
Proportion of patients showing target expression (Maximum Standardized Uptake Value (SUVmax) equal to or greater than 2.3) in brain lesion as measured by PET/CT.
Time frame
Up to two monthsSecondary outcomes
1
Percentage of intracranial (IC) lesions
Percentage of IC lesions showing PET/CT targeted expression (SUVmax equal to or greater than 2.3).
Time frame
Up to two months2
Percentage of extracranial (EC) lesions
Percentage of EC lesions showing PET/CT targeted expression (SUVmax equal to or greater than 2.3).
Time frame
Up tp two months3
Maximum standardized uptake value
The maximum standardized uptake value (SUVmax and Mean Standardized Uptake Value (SUVmean)) in brain lesions and their relative values compared to normal liver and blood pool activity.
Time frame
Up to two months4
Incidence of Diagnostic radioligand-Emergent Adverse Events (Safety and tolerability)
Determine the safety and toxicity profile of the selected diagnostic radioligand in patients with advanced solid tumors and active BMs according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0).
Time frame
Up to two monthsLocations
Source ClinicalTrials.gov
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