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

Sponsor
MedSIR
Study ID
NCT07178938
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 17, 2025
Start date
Apr 30, 2026
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm A

Primary Outcome Measure

Proportion of patients showing target expression [ Time Frame: Up to two months ]

Central Contacts

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