NL-OMON53401尚未招募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 - Not applicable
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 18
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
- •Inclusion Criteria for Enrollment into Part 1
- •1. Has never received AMB-05X in another study.
- •2. Male or female >=18 years of age.
- •3. Able to understand and willing to adhere to the requirements of this study.
- •Voluntarily signs the
- •ICF before the conduct of any study-specific procedures.
- •4. TGCT with only 1 joint involvement that has been diagnosed histologically by
- •a pathologist. If a
- •histological diagnosis has not been made previously, biopsy with
- •histological diagnosis is required
- •before enrollment
- •a. Individuals with TGCT of the knee joint are eligible in all
- •cohorts. Depending on results in
- •Cohort A and the recommendations of the DMC, individuals with TGCT
- •of the hip, and
- •shoulder joint may also be allowed after Cohort A.
- •b. Individuals with TGCT that are amenable or non-amenable to surgery
- •are eligible.
- •5. Measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI scans
- •radiology review.
- •6. If the subject uses prescription analgesic, subject must be on a stable
- •prescription analgesic
- •regimen during the 2 weeks before Baseline.
- •7. Agrees to follow contraception guidelines.
- •8. Adequate hematologic, hepatic, and renal function at Screening, defined by:
- •a. Absolute neutrophil count >= 1.0 × 109/L
- •b. Hemoglobin > 10 g/dL
- •c. Platelet count >= 100 × 109/L
- •d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 1.5 ×
- •upper limit of normal (ULN)
- •e. Total bilirubin <= 1.5 × ULN (elevated bilirubin secondary to a known,
- •largely benign condition [eg, Gilbert*s syndrome] is not exclusionary)
- •f. Creatinine clearance >= 45 mL/min/1.73 m2 (measured or estimated)
- •9. Symptomatic TGCT defined as at least 1 of the following:
- •a. A BPI worst pain score (Question #3, Appendix 3) of at least 4 before
- •dosing at Baseline.
- •b. A Worst Stiffness NRS score (Appendix 2) of at least 4 before dosing at
- •Inclusion Criteria for Enrollment into Part 2 without Completing Part 1
- •A subject may be enrolled directly into Part 2 of this study without completing
- •Part 1 if ALL of the following criteria are met:
- •1. Have measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI
- •scans by central radiology review, assessed from MRI scans by central radiology
- •review, and received treatment in Study AMB-051-01.
- •2. Able to understand and willing to adhere to the requirements of this study.
- •Voluntarily signs the ICF before the conduct of any study-specific procedures.
- •3. Agrees to follow contraception guidelines
- •4. Adequate hematologic, hepatic, and renal function at Screening, defined by:
- •a. Absolute neutrophil count >= 1.0 × 109/L
- •b. Hemoglobin > 10 g/dL
- •c. Platelet count >= 100 × 109/L
- 另有 8 项未显示
排除标准
- •1. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is
- •longer) before Study Baseline (other than AMB-05X in Study AMB-051-01 for
- •individuals enrolling directly into Part 2).
- •2. Use of any of the following:
- •a. Pexidartinib, any other oral tyrosine kinase inhibitor (eg, imatinib or
- •nilotinib), or any biologic
- •treatment targeting CSF1 or CSF1R (except AMB-05X), within 3 months before the
- •Baseline visit
- •b. Current or recent (within 10 days before starting study treatment) full-dose
- •oral anticoagulants (eg,
- •warfarin), daily treatment with high-dose aspirin (>325 mg/day) or
- •clopidogrel (>75 mg/day).
- •3. History of extensive or reconstructive surgery on the affected joint (eg,
- •involving plates, screws, or
- •metal implants). A history of prior diagnostic or partial synovectomy is
- •not exclusionary if
- •performed at least 3 months before Study Baseline.
- •4. Current or prior radiotherapy within 3 months before Study Baseline.
- •5. Current or prior active cancer within 3 years before Study 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.
- •6. Known metastatic TGCT or malignant transformation of TGCT.
- •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
- •10. A female who is pregnant or breastfeeding. For females of childbearing
- •potential, a positive
- •pregnancy test at either Screening or Study Baseline will be exclusionary.
- •11. A screening QT interval corrected using Fridericia*s formula (QTcF) >= 470 ms
- •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 Study Baseline.
- •15. 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. An individual who is held in detention as the result of a judicial or
- •official decision or who is in a
- 另有 7 项未显示
研究者
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