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

Apollomics, Inc.0 个研究点目标入组 497 人开始时间: 2020年4月3日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 497

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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.Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent
•before any study-specific procedure is performed.
•2. 18 years of age or older.
•3. For Phase 1, histologically and / or cytologically confirmed unresectable or metastatic solid malignancy, refractory to standard
•therapies with no more than three prior lines of therapy
•4.For Phase 2, nine cohorts will be enrolled: Cohort A-1 (all countries except Finland); Cohort A-2; Cohort B (Enrollment Completed); Cohort C; Cohort C-1; Cohort C-2, Cohort D, Cohort E and Cohort F; For detailed Cohort information please refer to the Protocol Amdt 10 dated 11AUG2023
•5. In Phase 2, provision of sample e.g. archival or a fresh tumor biopsy sample (if safe and feasible) either from the primary or a metastatic site or liquid biopsy sample (if tumor tissue insufficient or lacking, and approved by the sponsor) is required for prospective central lab confirmation for study entry.
•6. Treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed.
•7. Presence of =1 measurable lesion (scan done <=28 days of C1D1) to
•serve as target lesion according to relevant criteria (RECIST v1.1, RANO for CNS tumors, or other relevant criteria per tumor type) prospectively
•confirmed by the Independent Review Committee (IRC).
•8. ECOG performance status of 0–1. For subjects with primary CNS tumors, KPS score =70.
•9. Acceptable organ function, as evidenced by the following laboratory data during Screening period:
•a. Aspartate aminotransferase (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 creatinine clearance (CrCl) = 60 mL/min as calculated by the Cockcroft-Gault method
•g. Hemoglobin = 9 g/dL.
•10. For all prior anticancer treatment, including radiotherapy, chemotherapy or targeted agents (except EGFR-I for Cohort C2) or hormonal therapy, a duration of 30 days or 5 half-lives of the agents used, whichever is shorter, must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria prior to the first dose of study treatment. Palliative radiotherapy to non target lesions should be completed within 2 weeks prior to APL-101 administration. Subjects with glioblastoma (GBM) on Optune® therapy may be allowed if the following criteria are met: Must agree to switch off Optune ® at least 3 days prior to C1D1 and during the study; All AEs associated with Optune ® use must be resolved to Grade = 1 at least 3 days prior to C1D1. An MRI/CT scan is performed after discontinuation of Optune ®.
•11. Adequate cardiac function with left ventricular ejection fraction (LVEF) = 50% at screening.
•12. Women of child-bearing potential (WOCBP) must have a negative serum or ß-human chorionic gonadotropin (ß-hCG) or evidence of postmenopausal status.
•13. All subjects with reproductive potential must agree to use of effective contraceptive measures
•14. Resolution of all chemotherapy, radiotherapy or surgery-related AEs to Grade = 1, except for alopecia. Subjects who experienced significant
•complications with prior immuno-oncology (IO) therapy or EGFR-Inhibitor therapy or Grade

排除标准

•Subjects meeting any of the following exclusion criteria will be excluded
•from the study:
•1. Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
•2. Known actionable mutation/gene rearrangement of EGFR (except for NSCL subjects Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
•3. Use or intended use of any other investigational product, including herbal medications, 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. Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical
•therapy, history of congenital prolonged QT syndrome, prolonged QT interval corrected by Fridericia formula (QTcF) at screening (> 450 msec
•based on the average of 3 measurements), or concurrent treatment with a medication that is a known risk for prolonging the QT interval. Chronic controlled atrial fibrillation is not excluded.
•7. 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 and human immunodeficiency virus (HIV) positive subjects who are not clinically
•stable or controlled on their medication (asymptomatic subjects with CD4+ T-cell (CD4+) counts = 350 cells/µL and have not had an
•opportunistic infection within the past 12 months prior to first dose of APL-101 would be eligible for study entry. If history is unclear, relevant
•test(s) at Screening will be required to confirm eligibility.
•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. History of another malignancy within 3 years prior to C1D1. A subject with the following malignancies is allowed if considered cured or
•unlikely to recur within 3 years:
•a. Carcinoma of the skin without melanomatous features.
•b. Curatively treated cervical carcinoma in situ.
•c. Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment,
•prostate cancer which has been surgically or medically treated and not likely to recur within 3 years.
•13. Subjects who are unable or unwilling to discontinue excluded medications (drugs with known QTc risk and known strong cytochrome
•P450 [CYP]3A4 inducer and/or strong inhibitors) for at least 5 half lives prior to first dose of study drug. Sub

研究者

发起方

Apollomics, Inc.

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