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A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

Tenosynovial Giant Cell Tumor Clinical Trial

Official title:
A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor

Clinical Trial Summary

AMB-051-07 is an Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension which will enroll approximately 48 adult subjects with TGCT for IA doses over a 24-week dosing period (Part 1) with a Part 2 OLE of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05349643
Study type Interventional
Source AmMax Bio, Inc.
Contact Tiffany Nguyen
Phone 6502856560
Email clinical@ammaxbio.com
Status Recruiting
Phase Phase 2
Start date January 26, 2023
Completion date January 2026
View Details
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