CompletedPhase 2

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

United States, Australia20 participantsStarted 2023-01-26

Plain-language summary

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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 within 3 months prior to Baseline
✕. History of extensive or reconstructive surgery on the affected joint
✕. Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
✕. Metastatic or malignant transformation of TGCT
✕. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
✕. Known active tuberculosis
✕. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history

Objective Response Rate - Part 1

Timeframe: Part 1 Week 24

Treatment-emergent adverse events

Timeframe: Part 1 Week 24 and Part 2 Week 72

NCT IDNCT05349643

SponsorAmMax Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-03