Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
AmMax Bio, Inc is recruiting patients for the clinical trial of A Phase 2 Efficacy and Safety Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients.
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.
The researchers plan that June 16, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in January 31, 2023.
Among primary outcome measures are the Overall tumor response per RECIST and Proportion of subjects achieving overall tumor response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
The study will take place at the AmMax Bio Clinical Site, Berlin, Germany; AmMax Bio Clinical Site, Dnipro, Ukraine; AmMax Bio Clinical Site, Kharkiv, Ukraine; AmMax Bio Clinical Site, Kyiv, Ukraine.
Inclusion Criteria: 1. Subject ≥ 18 years 2. A confirmed diagnosis of TGCT 3. Measurable disease based on RECIST v1.1 4. Symptomatic disease 5. Stable prescription of analgesic regimen 6. Agrees to follow contraception guidelines 7. Adequate hematologic, hepatic, and renal function, at Screening 8. Willing and able to complete self-assessment instruments throughout the study.
Exclusion Criteria: 1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline 2. Current or prior radiotherapy within 3 months before Baseline 3. Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy) 4. Known metastatic TGCT or malignant transformation of diffuse-type TGCT 5. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV) 6. Known active tuberculosis (TB) 7. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history 8. Women who are pregnant or breastfeeding 9. Screening Fridericia-corrected QT interval(QTcF) ≥450ms (men) or ≥470ms (women) 10. MRI contraindications (eg, pacemaker, loose metallic implants) 11. History of hypersensitivity to any ingredient in the study drug 12. History of drug or alcohol abuse within 3 months before Baseline 13. 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 14. 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 15. 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
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04938180.
