NCT05908773

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

An Open-Label, Single-Center, Phase 0, Microdose Study to Demonstrate Delivery of TTX-MC138-NODAGA-Cu64 to Radiographically Confirmed Metastases in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: TransCode Therapeutics · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TTX-MC138-NODAGA-Cu64	TTX-MC138-NODAGA-Cu64 solution was developed as a PET radiopharmaceutical to permit assessment of delivery of TMX-MC138 to metastatic lesions in subjects with solid tumors. Subjects will be administered a microdose of TTX-MC138-NODAGA-Cu64 injection administered intravenously followed by whole body PET imaging.

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-08-23
• Completion: 2023-09-18
• First posted: 2023-06-18
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study