EUCTR2020-004870-22-DE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female =18 years of age.
- •2. Able to communicate well with study staff and understand and comply with the requirements of the study. Reads and voluntarily signs the informed consent form (ICF) and the Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) before the conduct of any study-specific procedures.
- •3. TGCT that has been histologically confirmed by a pathologist. If the diagnosis has not been previously histologically confirmed, biopsy with histological confirmation is required before enrollment.
- •4. Measurable disease as defined by RECIST v1.1 (except with a minimum size of 2 cm), assessed from MRI scans by a central radiologist.
- •5. If subject uses prescription analgesic, subject must be on a stable prescription analgesic regimen during the 2 weeks before Baseline.
- •6. Agrees to follow contraception guidelines.
- •7. Adequate hematologic, hepatic, and renal function at Screening, defined by:
- •Absolute neutrophil count = 1.5 × 109/L
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 1.5 × upper limit of normal (ULN)
- •Hemoglobin > 10 g/dL
- •Total bilirubin = 1.5 × ULN (elevated bilirubin secondary to a known, relatively benign condition [eg, Gilbert’s syndrome] is not exclusionary)
- •Platelet count = 100 × 109/L
- •Serum creatinine = 1.5 × ULN
- •8. Willing and able to complete the PROMIS Physical Function Scale, Worst Stiffness NRS, BPI, and EQ-5D-5L throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) before Baseline.
- •2. Use of pexidartinib, any other oral tyrosine kinbase inhibitor (eg, imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R within 3 months before Baseline.
- •3. Current or prior radiotherapy within 3 months before Baseline.
- •4. Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy), except adequately treated basal or squamous cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix or breast, or prostate carcinoma not requiring treatment apart from active surveillance.
- •5. Known metastatic TGCT or malignant transformation of diffuse-type TGCT.
- •6. Any history of complex or reconstructive surgery on the affected joint (eg, involving plates, screws, or metal implants).
- •7. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immunodeficiency virus (HIV).
- •8. Known active tuberculosis (TB).
- •9. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with the subject’s study participation or the interpretation of the subject’s results.
- •10. A woman who is pregnant or breastfeeding. For women of childbearing potential, a positive pregnancy test at either Screening or Baseline will be exclusionary.
- •11. A screening Fridericia-corrected QT interval (QTcF) =450 ms (men) or =470 ms (women)
- •12. MRI contraindications (eg, pacemaker, loose metallic implants)
- •13. History of hypersensitivity to any ingredient in the study drug.
- •14. History of drug or alcohol abuse within 3 months before Baseline.
- •15. 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.
- •16. 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.
- •17. A subject who, in the opinion of the Investigator, should not participate in this study for any reason, including instances where the subject’s stability or ability to comply with study requirements is in question.
研究者
相似试验
进行中（未招募）
1 期
A Study to evaluate treatment with intravenous AMB-05X in subjects with Tenosynovial Giant Cell TumorTenosynovial Giant Cell TumorMedDRA version: 21.0Level: LLTClassification code 10018253Term: Giant cell tumor of tendon sheathSystem Organ Class: 100000004864EUCTR2020-004870-22-NLAmMax Bio., Inc.36
进行中（未招募）
1 期
A Study to evaluate treatment with intravenous AMB-05X in subjects with Tenosynovial Giant Cell TumorTenosynovial Giant Cell TumorMedDRA version: 21.0Level: LLTClassification code 10018253Term: Giant cell tumor of tendon sheathSystem Organ Class: 100000004864EUCTR2020-004870-22-CZAmMax Bio., Inc.36
进行中（未招募）
1 期
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 TumorTenosynovial Giant Cell TumorMedDRA version: 21.0Level: LLTClassification code 10018253Term: Giant cell tumor of tendon sheathSystem Organ Class: 100000004864EUCTR2020-004870-22-PLAmMax Bio., Inc.36
尚未招募
2 期
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 TumorGiant cell tumor10013361NL-OMON50912AmMax Bio Inc6
进行中（未招募）
不适用
A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)Growth Hormone DeficiencyMedDRA version: 12.1Level: PTClassification code 10056438Term: Growth hormone deficiencyEUCTR2010-021523-28-SEAscendis Pharma A/S36