MedTrace Logo

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

NCT05908773 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • TransCode Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2023-08-23
Completion
2023-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908773 on ClinicalTrials.gov