NCT06260774

Study of TTX-MC138 in Subjects With Advanced Solid Tumors

A Phase 1/2 Multicenter, Open-Label, Dose-escalation and Expansion Study of TTX-MC138 in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: TransCode Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors

Detailed description

The study will consist of 2 phases, dose escalation and dose expansion, with 3 study periods: Screening (up to 28 days), Treatment (28-day treatment cycles, with dosing on Day 1), and Survival Follow-up (every 3 months). Each 28-day cycle is comprised of 1 dose of study drug administered as an intravenous (IV) infusion on Day 1. A subject will continue on treatment until a dose limiting toxicity (DLT) is observed, other adverse event (AE) leading to unacceptable toxicity as assessed by the Investigator, progression of disease, or withdrawal of consent.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TTX-MC138	The starting dose of TTX-MC138 in the first cohort will be 0.4 mg/kg and will be increased incrementally in subsequent cohorts until maximum tolerated dose (MTD) determination.

Timeline

• Start date: 2024-09-05
• Primary completion: 2025-09-30
• Completion: 2027-02-01
• First posted: 2024-02-15
• Last updated: 2025-10-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study