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Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases

NCT07178938 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)

Patients 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.

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-11-30
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178938 on ClinicalTrials.gov