Suspended
A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects With Tenosynovial Giant Cell Tumor
What is being tested
AMB-05X
Biological
Who is being recruted
Giant Cell Tumor of Tendon Sheath+9
+ Giant Cell Tumors
+ Joint Diseases
Over 18 Years
+23 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: September 2021
Summary
Principal SponsorAmMax Bio, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 16, 2021
Actual date on which the first participant was enrolled.AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R).
Official TitleA Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects With Tenosynovial Giant Cell Tumor
Principal SponsorAmMax Bio, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
4 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Giant Cell Tumor of Tendon SheathGiant Cell TumorsJoint DiseasesMuscular DiseasesMusculoskeletal DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueSynovitisSynovitis, Pigmented VillonodularNeoplasms, Connective and Soft TissueTendinopathy
Criteria
8 inclusion criteria required to participate
Subject ≥ 18 years
A confirmed diagnosis of TGCT
Measurable disease based on RECIST v1.1
Symptomatic disease
Show More Criteria
15 exclusion criteria prevent from participating
Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
Current or prior radiotherapy within 3 months before Baseline
Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy)
Known metastatic TGCT or malignant transformation of diffuse-type TGCT
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalEach subject will receive a low dose of AMB-05X every 2 weeks, for a total of 6 doses over the 12-week treatment period.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Suspended
Suspended
AmMax Bio Clinical Site
Warsaw, PolandSuspended
AmMax Bio Clinical Site
Dnipro, UkraineSuspended
AmMax Bio Clinical Site
Kharkiv, UkraineSuspended5 Study Centers