KCT0008450尚未招募Unknown
A phase II study of ABN401 in advanced solid tumors with c-MET gene aberration (Part of KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors [KOSMOS]-II)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Informed consent for KOSMOS-II master observation study
- •2) Male or female =19 years of age
- •3) Histologically confirmed advanced solid cancers who harboring c-MET alterations (patients who performed NGS tests and c-MET alterations confirmed in molecular tumor board [MTB])
- •? exon 14 skipping mutation except for non-small cell lung cancer (NSCLC)
- •? c-MET amplification GCN (gene copy no.) =6 by NGS
- •? Fluorescence/Silver In situ hybridization (FISH/SISH) result of the MET/CEP7 ratio =2
- •? Other MET alterations that are regarded to be actionable by the KOSMOS MTB
- •4) Disease progression during or after standard therapy and without further treatment options, or no standard therapy, or ineligible for standard therapy
- •5) At least one measurable or evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •6) Eastern Cooperative Oncology Group Performance Status 0-2
- •7) Capable to eat food
- •8) Adequate organ functions
- •? Absolute neutrophil count (ANC) =1500/mm3 (ie, 1.5×109/L by International Unit [IU]); excluding measurements obtained within 7 days after administration of granulocyte colony stimulating factor (G-CSF)
- •? Platelet count =75000/mm3 (IU: =75×109/L); excluding measurements obtained within 7 days after transfusion of platelets.
- •? Hemoglobin value of =8.0 g/dL
- •? AST/ALT =3×upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST / ALT =5×ULN
- •? Total serum bilirubin of =1.5×ULN
- •? Creatinine clearance (CrCl) of =50 mL/min (MDRD)
- •9) Have a life expectancy of at least 90 days
- •10) If not menopausal or surgically sterile, willing to practice at least
- •one of the following highly effective methods of birth control for at least a (partner’s) menstrual cycle before and for 3 months after study drug administration:
- •? Barrier type devices (examples are condom, diaphragm, and contraceptive sponge) used only in combination with a spermicide
- •? Sexual intercourse with vasectomized male/sterilized female partner
- •? Hormonal female contraceptive (oral, parenteral, intravaginal, implantable, or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers)
- •? Use of an intrauterine contraceptive device
- •? Note: Abstinence, the rhythm method, and/or contraception by the partner are not acceptable methods of birth control
- •11) Willing to provide available tissue specimens and consent to blood collection for evaluation of biomarkers
- •Archival tissue specimens: formalin-fixed, paraffin-embedded tissues
- •Optional fresh tissue collection prior to ABN401 administration
排除标准
- •1) Previous treatment with c-MET inhibitor
- •2) NSCLC with c-MET exon 14 skipping mutation
- •3) Previous hypersensitivity reaction to any component of study drugs
- •4) Presence or history of arrhythmia
- •5) Past history of
- •? Major surgery within 4 weeks before study (must have complete recovery from surgical complications)
- •? Radiotherapy within 4 weeks before study or limited radiotherapy within 2 weeks
- •? Chemotherapy or biologic agents within 3 weeks before study (targeted therapy within 2 weeks and mitomycin within 5 weeks)
- •6) History of the following medical conditions
- •? Active central nervous system (CNS) metastasis (clinically unstable after stopping steroid for more than 2 months)
- •? Leptomeningeal metastasis
- •? Acute systemic infection
- •? Acute myocardial infarction, stable/unstable angina, symptomatic heart failure ((New York Heart Association [NYHA] class III or IV within the previous 6 months; if >6 months cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms)
- •? Clinically critical chronic vomiting or diarrhea
- •? Uncontrolled hypertension (systolic blood pressure >150mmHg diastolic blood pressure>100mmHg)
- •? Proteinuria (urine dipstick or 24-hour urine collection > 1.0g): must have 24-hour urine collection if baseline urine dipstick =2+
- •? Active HBV/ HCV except for
- •· HBsAg (+) with undetectable HBV DNA
- •· If HBsAg (+) and HBV DNA (+), chronic state of infection and clinically stable after anti-viral therapy for more than 3 months
- •· If IgG anti-HBc (+) and past history of HBV infection, undetectable HBV DNA
- •· HCV Ab (+) with undetectable HCV RNA
- •? Severe psychiatric disorders
- •? Concurrent anticoagulants at therapeutic dose
- •? Past history of gastrointestinal perforation or fistula within 3 months before study, grade 3 or 4 of gastrointestinal bleeding/varix
- •7) Toxicity with prior therapy (> grade 1) (except for alopecia, pigmentation, poor oral intake), and neuropathy (> grade 1)
- •8) Pregnant or breastfeeding
- •9) Patients with a corrected QT interval (using Fridericia’s correction formula) (QTcF) of > 470 msec
研究者
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