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AMB-05X for Pigmented Villonodular Synovitis
Phase 2
Waitlist Available
Research Sponsored by AmMax Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject ≥ 18 years
A confirmed diagnosis of TGCT of the knee joint
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study Summary
This trial will study the effects of AMB-05X on subjects with TGCT of the knee.
Eligible Conditions
- Giant Cell Tumor
- Pigmented Villonodular Synovitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment-emergent adverse events
Tumor response based on RECIST
Secondary outcome measures
EQ-5D-5L Health Assessment
Mean change from Baseline in Worst Pain NRS score
Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AMB-05XExperimental Treatment1 Intervention
Subjects will receive an injection of AMB-05X once every 2 weeks for 12 weeks (for 6 treatments total).
Based on ongoing review of the available safety, PK, PD, and efficacy data, the Sponsor may either increase or decrease the dose.
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Who is running the clinical trial?
AmMax Bio, Inc.Lead Sponsor
5 Previous Clinical Trials
194 Total Patients Enrolled
Michael Huang, MDStudy ChairAmMax Bio, Inc.
4 Previous Clinical Trials
41 Total Patients Enrolled
Dorothy Nguyen, MDStudy ChairAmMax Bio, Inc.
5 Previous Clinical Trials
590 Total Patients Enrolled
Frequently Asked Questions
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