Advanced Solid Tumors, Lymphoma
Conditions
Brief summary
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
Interventions
DRUGKN046
Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks. Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia.
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent; willing and able to complete all required procedures of study. 2. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected. 3. Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma. 4. ECOG performance status of 0 or 1. 5. Subject must have adequate organ function. 6. Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed. 7. Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.
Exclusion criteria
1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. 2. Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment. 3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment. 4. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. 5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded. 6. Active HBV or HCV infection. 7. Known HIV infection or known history of acquired immune deficient syndrome (AIDS). 8. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia. 9. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In the dose escalation part, number of participants with dose limiting toxicity (DLT). | During the first 4 weeks of treatment. | — |
| In the dose expansion part,Objective response rate (ORR). | up to 2 years. | Objective response is defined as complete response (CR) or partial response (PR) |
| In the dose expansion part, Duration of response (DoR). | up to 2 years. | Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first. |
Countries
China
Outcome results
None listed