Viewing Study NCT06260774



Ignite Creation Date: 2024-05-06 @ 8:07 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06260774
Status: RECRUITING
Last Update Posted: 2024-07-03
First Post: 2023-12-12

Brief Title: Study of TTX-MC138 in Subjects With Advanced Solid Tumors
Sponsor: TransCode Therapeutics
Organization: TransCode Therapeutics

Study Overview

Official Title: A Phase 12 Multicenter Open-Label Dose-escalation and Expansion Study of TTX-MC138 in Subjects With Advanced Solid Tumors
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A Phase 12 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None