NL-OMON50912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 Tumor - A Study to evaluate treatment with IV AMB-05X in subjects with TGCT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female >=18 years of age.
- •2. Able to communicate well with study staff, understand and comply with the
- •requirements of the study, and read and voluntarily sign the informed consent
- •form (ICF) before the conduct of any study-specific procedures. .
- •3. TGCT that meets both of the following criteria:
- •a. Diagnosis has been histologically confirmed by a pathologist. If the
- •diagnosis has not been previously histologically confirmed, biopsy with
- •histological confirmation is required before enrollment.
- •b. Has not been surgically resected either because surgical resection would be
- •associated with potentially worsening functional limitation/ severe morbidity
- •(locally advanced disease) or because the subject declined surgery.
- •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. Symptomatic disease defined as one or both of the following:
- •a. A score of at least 4 on the Worst Pain NRS at Screening.
- •b. A score of at least 4 on the Worst Stiffness NRS at Screening.
- •6. Stable prescription of analgesic regimen during the 2 weeks before Baseline.
- •7. Women of childbearing potential must have a negative serum pregnancy test at
- •Screening and a negative urine pregnancy test at Baseline.
- •8. Agrees to follow contraception guidelines (see Section 5.3).
- •9. 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
- •Platelet count >= 100 × 109/L
- •Serum creatinine <= 1.5 × ULN
- •10. Willing and able to complete the PROMIS Physical Function Scale, Worst
- •Stiffness NRS, BPI, and EQ-5D-5L throughout the study.
排除标准
- •1. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is
- •longer) before baseline.
- •2. Any previous use of pexidartinib or any biologic treatment targeting CSF1 or
- •CSF1R. Use of an oral tyrosine kinase inhibitor other than pexidartinib (eg,
- •imatinib or nilotinib) within 3 months before Baseline.
- •3. Active cancer (either currently or within 1 year before Baseline) that
- •requires/required therapy (eg, surgery, chemotherapy, or radiation therapy),
- •with the exception of 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.
- •4. Known metastatic TGCT.
- •5. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or
- •chronic infection with human immunodeficiency 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 that, in the
- •Investigator's opinion, would likely interfere with the subject*s study
- •participation or the interpretation of the subject*s results.
- •8. A woman who is breastfeeding.
- •9. A screening Fridericia-corrected QT interval (QTcF) >=450 ms (men) or >=470 ms
- •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 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
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