A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    36
  • sponsor
    AmMax Bio, Inc.
Updated on 18 July 2021

Summary

The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of patients with TGCT.

Details
Condition Pigmented villonodular synovitis, Tenosynovial Giant Cell Tumor, tgct, testicular germ cell tumour
Treatment AMB-05X
Clinical Study IdentifierNCT04938180
SponsorAmMax Bio, Inc.
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject 18 years
A confirmed diagnosis of TGCT
Measurable disease based on RECIST v1.1
Symptomatic disease
Stable prescription of analgesic regimen
Agrees to follow contraception guidelines
Adequate hematologic, hepatic, and renal function, at Screening
Willing and able to complete self-assessment instruments throughout the study

Exclusion Criteria

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
Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV)
Known active tuberculosis (TB)
Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
Women who are pregnant or breastfeeding
Screening Fridericia-corrected QT interval(QTcF) 450ms (men) or 470ms (women)
MRI contraindications (eg, pacemaker, loose metallic implants)
History of hypersensitivity to any ingredient in the study drug
History of drug or alcohol abuse within 3 months before Baseline
Has any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment, interfere with interpretation of study results, or, in the Investigator's opinion, make the subject inappropriate for this study
A person who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the Sponsor or Investigator
A subject who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the subject's ability to comply with study requirements
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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