An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

Alphamab (Australia) Co Pty Ltd0 个研究点目标入组 53 人开始时间: 2018年5月21日最近更新: 2019年10月28日

适应症

试验速览

暂无简介。

•Signed written informed consent.
•-Confirmed Advanced solid tumors.
•-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•-Adequate organ function within 3 weeks prior to commence of treatment.
•-Able to comply comply with study requirements.
•-Female participants and male participants with partners of childbearing potential must use highly effective contraceptive measures (with a failure rate of less than 1% per year).
•-All participants must agree to use contraception for a period of 24 weeks after dosing has been completed.
•-Negative serum or urine pregnancy test required for female participants and they must not be breastfeeding.

•-Subjects with brain metastases or leptomeningeal.
•-Receipt of any immunotherapy, any conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose of KN046.
•-Prior treatment or with sequential monotherapy with anti-CTLA-4 and anti-PD-1/PD-L agents.
•-Patients who have received monotherapy with PD-L1 / PD-1, CTLA4 or other antibodies and had intolerable toxicity or required steroids to manage toxicity.
•-History of, or currently active, or suspected, autoimmune or inflammatory disorders.
•-A current or prior use of immunosuppressive medication within 14 days of the 1st dose of study treatment.
•-Any unresolved toxicity greater than or equal to NCI CTCAE Grade 2 from previous anticancer therapy.
•-Confirmed heart diseases, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, Acute coronary syndrome within 6 months prior to starting treatment, Baseline LVEF (Left ventricular ejection fraction) less than or equal to 55% measured by echocardiography or MUGA, et, al.
•-Uncontrolled hypertension.
•-Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus 1/2 antibody (HIV 1/2 Ab).
•-History of severe allergic reactions to any unknown allergens or known allergy or reaction to any component of the KN046 formulation.

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