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Brief Title: An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
Official Title: An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
Study ID: NCT04731675
Brief Summary: AMB-051-01 is a multicenter study with an adaptive design that will enroll approximately 12 subjects with TGCT of the knee for 12 weeks of multiple-dose, open-label treatment with AMB-05X.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AmMax Bio Clinical Site, Columbus, Ohio, United States
AmMax Bio Clinical Site, Leiden, , Netherlands
AmMax Bio Clinical Site, Warsaw, , Poland
AmMax Bio Clinical Site, Dnipro, , Ukraine
AmMax Bio Clinical Site, Kharkiv, , Ukraine
AmMax Bio Clinical Site, Kyiv, , Ukraine
Name: Dorothy Nguyen, MD
Affiliation: AmMax Bio, Inc.
Role: STUDY_CHAIR