None listed
Conditions
Brief summary
This is an open-label, multi-center, dose-escalation phase I study. The primary purpose of this trial is to evaluate the safety and tolerability as well as the preliminary efficacy of KN046 in participants with advanced solid tumors. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced malignant solid tumor with no standard therapy is available. Study details All participants enrolled in this trial will receive KN046 intravenously every two weeks for 6 months or until excessive toxicity, disease progression, patient consent withdral, physician's judgment (whichever occurs first), up to 2 years. The dose received by each participant depends on the time of their enrolment. KN046 is a biological drug for treatment of advanced solid tumor. As a part of the clinical research study patients will have regular blood tests, physical examinations, Tumor imaging examinations by either CT or MRI. It is hoped this study will contribute important safety and efficacy information as well as to determined the optimal dose of KN046 to administer for treatment.
Interventions
This is single-arm dose-escalation trial, All participants will receive treatment with KN046. Participants enrolled in this trial may receive one of the following doses dependent upon time of enrolment into the study.
Cohort 1: 0.3 mg/kg
Cohort 2: 1 mg/kg
Cohort 3: 3 mg/kg
Cohort 4: 5 mg/kg
Cohort 5: 10 mg/kg
KN046 will be given as an intravenous infusion over 60 minutes every 2 weeks. Participants may receive treatment for 6 months or until excessive toxicity, disease progression, patient co
This is single-arm dose-escalation trial, All participants will receive treatment with KN046. Participants enrolled in this trial may receive one of the following doses dependent upon time of enrolment into the study. Cohort 1: 0.3 mg/kg Cohort 2: 1 mg/kg Cohort 3: 3 mg/kg Cohort 4: 5 mg/kg Cohort 5: 10 mg/kg KN046 will be given as an intravenous infusion over 60 minutes every 2 weeks. Participants may receive treatment for 6 months or until excessive toxicity, disease progression, patient consent withdral, physician's judgment (whichever occurs first).
Sponsors
Alphamab (Australia) Co Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-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.
Exclusion criteria
-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.
Outcome results
None listed