drugset / Trial / NCT07178938

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

NCT07178938 ↗

Phase 2 Not yet recruiting 10 enrolled MedSIR
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject [68Ga]Ga-DOTA-TOC Diagnostic / imaging agent 100 mbq Intravenous
Subject [68Ga]Ga-DOTA-TOC Diagnostic / imaging agent 200 mbq Intravenous