Microdose TTX-MC138-NODAGA-Cu64 for Advanced Cancer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: TransCode Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Adults with advanced solid tumors that can't be cured, who have good organ function and a certain level of blood cells. They must not need immediate standard therapy, be able to consent, and use effective contraception if they can have children. People with heart issues, uncontrolled diseases, recent other cancer treatments or surgeries aren't eligible.

Inclusion Criteria

My cancer has spread, cannot be cured with surgery or radiation, and joining this study won't delay my usual treatment.

Women of childbearing potential must employ highly effective contraception measures

I am 18 years old or older.

Exclusion Criteria

Pregnancy or breastfeeding

Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions

I have had another type of cancer in the last year.

Treatment Details

Interventions

• TTX-MC138-NODAGA-Cu64 (Virus Therapy)

Trial Overview The trial is testing TTX-MC138-NODAGA-Cu64 in patients with advanced solid tumors using PET-MRI scans to see how the drug spreads in the body and what its pharmacokinetics are (how it's absorbed, distributed, metabolized, and excreted). It's an early-phase study at one site for about 46 days.

Who Is Running the Clinical Trial?

TransCode Therapeutics

Lead Sponsor

Trials

2

Recruited

20+