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1m
New P2 trial
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AMB-05X
4ms
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT (clinicaltrials.gov)
P2, N=20, Completed, AmMax Bio, Inc. | Recruiting --> Completed | N=48 --> 20 | Trial completion date: Jan 2026 --> Jun 2024 | Trial primary completion date: Nov 2025 --> Jun 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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AMB-05X
5ms
Trial completion
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AMB-05X
6ms
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients (clinicaltrials.gov)
P2, N=4, Terminated, AmMax Bio, Inc. | Active, not recruiting --> Terminated; Further enrollment was halted in November 2021, enrolled subjects completed the study. Sponsor stopped further recruitment in this intravenous study to focus on intra-articular route of administration in subjects with tenosynovial giant cell tumor.
Trial termination
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AMB-05X
over2years
The synovial and systemic pharmacokinetics and pharmacodynamics of intra-articular administration of the CSF1 receptor antibody AMB-05X in a phase II proof-of-concept trial in tenosynovial giant cell tumor (ESMO 2022)
CSF1 levels in both compartments achieved a plateau, indicative of full receptor engagement, early in the treatment period. Conclusions The AMB-05X PK and PD results support expansion of the clinical development of AMB-05X in TGCT with IA treatment at a comfortable interval of once-monthly or less.
P2 data • PK/PD data
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CSF1R (Colony stimulating factor 1 receptor)
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AMB-05X
4years
Safety and efficacy of AMG 820, an anti-colony-stimulating factor 1 receptor antibody, in combination with pembrolizumab in adults with advanced solid tumors. (PubMed, J Immunother Cancer)
The recommended combination dose of 1100 mg AMG 820 plus 200 mg pembrolizumab had an acceptable safety profile. Although pharmacodynamic effects were observed, antitumor activity was insufficient for further evaluation of this combination in selected patient populations.
Journal • Combination therapy • PD(L)-1 Biomarker
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CSF1R (Colony stimulating factor 1 receptor)
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PD-L1 expression
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Keytruda (pembrolizumab) • AMB-05X