NCT04938180终止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 Tumor
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 5
- 主要终点
- Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.
详细描述
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Treatment-emergent Adverse Events (TEAEs)
时间窗: 6 months
The frequency and severity of reported TEAEs in Subjects with Tenosynovial Giant Cell Tumor (TGCT) receiving Intravenous AMB 05X.
次要结局
- Serum Cmax for AMB-05X at Week 10 Post Dose(10 weeks)
- Number of Subjects With Anti-Drug Antibodies to AMB-05X at Week 10(10 weeks)
- Mean Change From Baseline in Brief Pain Inventory Severity Interference(12 weeks)
- Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score(12 weeks)
- Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1(12 weeks)
- Overall Response Based on Tumor Volume Score (TVS)(24 weeks or ET visit)
- Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score(12 weeks)
- Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores(week 12)
- Mean Change From Baseline Rnge of Motion (Flexion, Ankle) Scores(week 12)
- Brief Pain Inventory Pain Severity Domain Score(12 weeks)
- Worst Pain Numeric Rating Scale Score(12 weeks)
- EuroQol 5 Dimension 5 Level Health Assessment(12 weeks)
- Colony-stimulating Factor 1 Levels(10 weeks)
- Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels(Week 12)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
2 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal HyperplasiaCAH - Congenital Adrenal HyperplasiaNCT03525886Neurocrine Biosciences18
已完成
2 期
Study of Infigratinib in Children With AchondroplasiaAchondroplasiaNCT04265651QED Therapeutics, Inc., a Bridgebio company84
已完成
2 期
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) AmyloidosisTTR-mediated AmyloidosisNCT01617967Alnylam Pharmaceuticals29
已完成
2 期
Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)Paroxysmal Nocturnal HemoglobinuriaPNHNCT02605993Alexion Pharmaceuticals, Inc.26
已完成
2 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal HyperplasiaCAH - Congenital Adrenal HyperplasiaNCT04045145Neurocrine Biosciences8