An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cel… (NCT04731675) | Clinical Trial Compass
CompletedPhase 2
An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
United States, Netherlands, Poland11 participantsStarted 2021-05-25
Plain-language summary
AMB-051-01 is a multicenter study with an adaptive design that will enroll subjects with Tenosynovial Giant Cell Tumor (TGCT) of the knee for 12 weeks of multiple-dose, open-label treatment with intra-articular AMB-05X.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject ≥ 18 years
✓. A confirmed diagnosis of tenosynovial giant cell tumor (TGCT) of the knee joint
✓. Measurable disease based on RECIST v1.1
✓. Stable prescription of analgesic regimen
✓. Negative urine drug screen (UDS) at Screening and Baseline
✓. Women of childbearing potential must have a negative pregnancy test
✓. Agrees to follow contraception guidelines
✓. Adequate hematologic, hepatic, and renal function, at Screening
Exclusion criteria
✕. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
✕. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors
✕. History of extensive knee surgery
✕. Active cancer (either currently or within 1 year before Baseline) that requires therapy (e.g., surgery, chemotherapy, or radiation therapy)
✕. Metastatic TGCT
✕. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events