Table of Contents
- Trial overview
- Study design and treatment plan
- Who participated
- What was measured
- Trial status and size
Trial overview
The main clinical trial of Amb-05X studied people with tenosynovial giant cell tumor (TGCT), a tumor that affects tissue around joints and tendons.[1] The study was designed to evaluate safety, tolerability, efficacy, and pharmacokinetics, which means how the treatment behaves in the body.[1]
Study design and treatment plan
This was a Phase 2, open-label, adaptive, dose-ranging study with a long-term extension.[1] Open-label means everyone knew which treatment was being given, and adaptive means the study could adjust parts of its plan as it went on.[1] The treatment was given as intra-articular injections, which means injections directly into a joint.[1]
Who participated
The study enrolled subjects with tenosynovial giant cell tumor.[1] The total enrollment was 47 people.[1] The trial data provided here do not list the full set of entry rules, so the most important target group is the patient group with TGCT.[1]
What was measured
The main outcome was the objective response rate at Week 24, based on central radiology review using RECIST v1.1.[1] Objective response means the tumor was judged to shrink or disappear on imaging, and RECIST v1.1 is a standard way to measure tumor change.[1] The study also measured the frequency and severity of treatment-emergent adverse events, which are medical problems that happen after treatment starts.[1]
The brief study summary also says the researchers looked at pharmacodynamics, which means the effects of the treatment in the body, during the first 24 weeks and during the extended follow-up period.[1]
Trial status and size
The trial status is completed.[1] It included 47 participants and was listed as an interventional study, meaning the researchers actively gave a treatment rather than only observing people.[1]
