This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Dose-limiting toxicity(DLT)
Dose-limiting toxicity
Time frame: 28 days
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Time frame: up to 2 years
Duration of response (DOR)
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Time frame: up to 2 years
Clinical benefit rate
Clinical benefit rate
Time frame: up to 2 years
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS) rates
Overall survival (OS) rates
Time frame: 6 months and 12 months
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