EUCTR2019-001757-54-IT进行中（未招募）1 期
Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors - SPARTA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 201
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.Men/women = 18 years of age or older able to understand and signICF before study.
- •2. For Ph 1, histologically and/or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy.
- •3.For Ph 2, five cohorts will be enrolled:
- •- 3a. Cohort A-1: EXON 14 NSCL Cancer – c-Met inhibitor naïve (1L)
- •- 3b. Cohort A-2: EXON 14 NSCL Cancer – c-Met inhibitor naïve (>2L)
- •- 3c. Cohort B: EXON 14 NSCL Cancer – c-Met inhibitor experienced
- •- 3d. Cohort C: Basket Tumor Types (c-Met high-level amplifications)
- •- 3e. Cohort D: Basket Tumor Types (c-Met fusions)
- •4.Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
- •Phase 1 (100, 200, and 300 mg Cohorts)
- •a. c-Met overexpression by IHC 2+ = 50% of tumor cells
- •b. or c-Met amplification (c-Met/Cep-7 ratio = 2.2 or GCN = 6 gene copy)
- •c. or c-Met EXON 14 skip mutation per NGS or RT-PCR
- •d. or c-Met fusions including the following, but not limited to this list (LIST): BAIAP2L1; C8orf34; CAPZA2; DCTN1; EPS15; LRRFIP1; MET; OXR1; PPFIBP1; PTPRZ1; TFG; TPR; TRIM4; ZKSCAN1; KIF5B and any other known c-Met activating mutations
- •Phase 1 (400 mg Cohort) and Phase 2 RP2D
- •a.c-Met high-level amplification (c-Met/Cep-7 ratio of = 2.2 or GCN of = 6 copy). A minimum of five subjects of the high-level amplification (c- Met/Cep-7 ratio of = 5 or GCN = 10 gene copy) for the Stage 1 of the Simon 2 stage design is required)
- •b.or c-Met EXON 14 skip mutation per NGS
- •c.or c-Met fusions including the following, but not limited to the LIST
- •d. or other c-Met mutations in Dose Escalation (400 mg Cohort)
- •5. Local/archival result of a positive c-Met dysregulation is required. In Ph 2, Cohorts A and D require provision of tumor tissue samples. For Cohorts B and C, provision of tumor tissue or plasma sample for entry is acceptable.
- •6. Across Ph 2 five cohorts, treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed.
- •7. Measurable disease according to RECIST v1.1. (or relevant criteria per tumor type).
- •8. ECOG performance status of 0–1.
- •9. Acceptable organ function, as evidenced by the following laboratory data during Screening period:
- •a.AST and alanine aminotransferase (ALT) = 2.5 x ULN
- •b.Total serum bilirubin = 1.5 x ULN
- •c.For subjects with liver metastases: Total bilirubin = 3.0 x ULN, AST/ALT = 5 x ULN
- •d.Absolute neutrophil count (ANC) = 1500 cells/mm3 (1.5 x 109/L)
- •e.Platelet count = 100,000 cells/mm3 (100 x 109/L)
- •f.Serum creatinine levels = 1.5 ULN or MDRD = 60 mL/min (CKD EPI
- •Creatinine Equation)
- •g.Hemoglobin = 9 g/dL
- •10.No chemotherapy treatments within at least 3 weeks prior to first dose of study treatment.
- •11.Adequate cardiac function or normal cardiac function with left ventricular ejection fraction (LVEF) =50% at screening.
- •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 121
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1.Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
- •2.Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS and BRAF.
- •3.Use or intended use of any other investigational product, including herbal medication through Study Treatment Termination.
- •4.Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the investigator makes the risk:benefit unfavorable for the participation of the trial. Screening for chronic conditions is not required.
- •5.Life-threatening illness, significant organ system dysfunction or comorbid conditions, or other reasons that, in the investigator's opinion, could compromise the subject's safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of APL-101.
- •6.History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval). 7.History of human immunodeficiency virus (HIV), or historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) with high viral loads not actively managed with antiviral therapy. If history is unclear, a test at Screening will be required.
- •8.Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
- •9.Unable to swallow orally administered medication whole.
- •10.Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- •11.Women who are breastfeeding.
- •12.Subjects with complications from prior radiation therapy will not be eligible until AEs return to baseline or = Grade 1.
- •13.Pregnant or breastfeeding woman.
研究者
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