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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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 more

Trial 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.

Find a Location

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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025