drugset / Trial / NCT05908773
A Microdose Study of TTX-MC138-NODAGA-Cu64 in Subjects With Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TTX-MC138-NODAGA-Cu64 | Diagnostic / imaging agent | — | Intravenous |