NCT05349643已完成2 期
A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Objective Response Rate - Part 1
研究概览
简要总结
AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor
详细描述
AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension which will enroll up to 48 adult subjects with tenosynovial giant cell tumor for intra-articular doses over a 24-week dosing period (Part 1) with a Part 2 open-label extension of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.
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
盲法说明
None (Open Label)
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
- •TGCT with only 1 joint involvement
- •Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
- •Stable prescription of analgesic regimen
- •Agrees to follow contraception guidelines
- •Women of childbearing potential must have a negative pregnancy test
- •Adequate hematologic, hepatic, and renal function
排除标准
- •Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
- •Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors within 3 months prior to Baseline
- •History of extensive or reconstructive surgery on the affected joint
- •Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
- •Metastatic or malignant transformation of TGCT
- •Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Known active tuberculosis
- •Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
- •Women who are breastfeeding
- •A screening Fridericia-corrected QT interval (QTcF) ≥ 470 ms
- •MRI contraindications (e.g., pacemaker, loose metallic implants)
- •History of hypersensitivity to any ingredient of the study drug
- •History of drug or alcohol abuse within 3 months before baseline
- •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 or interfere with interpretation of study results and, in the Investigator's opinion, make the subject inappropriate for this study
- •Subjects who, in the Investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements
研究组 & 干预措施
AMB-05X
Experimental
Subjects will receive an injection of AMB-05X once every 4 weeks for 24 weeks (for 6 treatments total). Based on ongoing review of the available safety, PK, PD, and efficacy data, the Sponsor may either increase or decrease the dose.
干预措施: AMB-05X (Biological)
结局指标
主要结局
Objective Response Rate - Part 1
时间窗: Part 1 Week 24
Proportion of subjects who achieve an OR (objective response rate \[ORR\]) by central radiology review per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Treatment-emergent adverse events
时间窗: Part 1 Week 24 and Part 2 Week 72
Frequency and severity of reported treatment-emergent adverse events
次要结局
- Objective Response Rate(Part 2 Week 72)
- Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score(Part 2 Week 72)
- Duration of Response by Modified Response Evaluation Criteria in Solid Tumors(Part 2 Week 72)
- Time to Response per tumor volume score(Part 2 Week 72)
- Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline(Part 2 Week 72)
- Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score(Part 2 Week 72)
- Mean change from Baseline in Worst Pain Numeric Rating Scale score(Part 2 Week 72)
- Objective Response Rate (AMB-051-01 subjects)(Part 2 Week 72)
- Mean change from Baseline in joint range of motion (ROM)(Part 2 Week 72)
- Mean change from Baseline in Worst Stiffness Numeric Rating Scale score(Part 2 Week 72)
- Duration of Response by Response Evaluation Criteria in Solid Tumors(Part 1 Week 24)
- Duration of Response by Response Evaluation Criteria in Solid Tumors v1.1(Part 2 Week 72)
- Duration of Response by tumor volume score(Part 2 Week 72)
- Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks(Part 2 Week 72)
- EuroQol 5 Dimension 5 Level Health Assessment(Part 2 Week 72)
- Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1(Part 2 Week 72)
- Tumor response based on tumor volume score (TVS)(Part 2 Week 72)
- Time to Response by Response Evaluation Criteria in Solid Tumors(Part 2 Week 72)
- Time to Response by Modified Response Evaluation Criteria in Solid Tumors(Part 2 Week 72)
- Mean change from Baseline in the Brief Pain Inventory (BPI) score(Part 2 Week 72)
- Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score(Part 2 Week 72)
- Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1(Part 1 Week 24)
- Tumor response based on tumor volume score (TVS)(Part 1 Week 24)
- Duration of Response by Modified Response Evaluation Criteria in Solid Tumors(Part 1 Week 24)
- Duration of Response by tumor volume score(Part 1 Week 24)
- Time to Response by Response Evaluation Criteria in Solid Tumors(Part 1 Week 24)
- Time to Response by Modified Response Evaluation Criteria in Solid Tumors(Part 1 week 24)
- Time to Response per tumor volume score(Part 1 Week 24)
- Mean change from Baseline in joint range of motion (ROM)(Part 1 Week 24)
- Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score(Part 1 Week 24)
- Mean change from Baseline in Worst Stiffness Numeric Rating Scale score(Part 1 Week 24)
- Mean change from Baseline in the Brief Pain Inventory (BPI) score(Part 1 Week 24)
- Mean change from Baseline in Worst Pain Numeric Rating Scale score(Part 1 Week 24)
- Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline(Part 1 Week 24)
- Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score(Part 1 Week 24)
- Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks(Part 1 Week 24)
- Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score(Part 1 Week 24)
- EuroQol 5 Dimension 5 Level Health Assessment(Part 1 Week 24)
研究者
研究点 (6)
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