drugset / Trial / NCT05908773

A Microdose Study of TTX-MC138-NODAGA-Cu64 in Subjects With Advanced Solid Tumors

NCT05908773 ↗

Phase 0 Completed 1 enrolled TransCode Therapeutics
NaSingle-groupOpen-labelOther

Summary

This is an open-label, single-center, single-arm, phase 0, microdose study in subjects with advanced solid tumors and radiographically confirmed metastases. The study will evaluate delivery of TTX-MC138-NODAGA-Cu64 radiographically and establish the PK and biodistribution of TTX-MC138-NODAGA-Cu64 as determined by PET-MRI. The study consists of 3 parts: a screening period, dosing period, and follow-up period. The estimated total duration of the study is approximately 46 days. Approximately 12 subjects with advanced metastatic solid tumors will be enrolled at 1 single site.

Timeline

Start
2023-04-04
Primary completion
2023-08-23
Completion
2023-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject TTX-MC138-NODAGA-Cu64 Diagnostic / imaging agent — Intravenous

Indications