Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03916094|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: HLX22||Phase 1|
This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22.
Four dose levels are designed for HLX22 in this study: 1, 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a BOIN design to assign doses to the patients, and thereby determine the MTD of HLX22.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 2021|
Experimental: HLX22 group
HLX22, at four dose levels (1, 3, 10, 25mg/kg), to be intravenously injected once every three weeks; Study drugs given until disease progression, one year of treatment, withdrawal from the study or death
Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody
Other Name: HER2 Monoclonal Antibody
- Maximum Tolerated Dose (MTD) of HLX22 in patients with advanced solid tumors overexpressing HER2 [ Time Frame: from day1 to day 42(cycle 1 and cycle2 ,each cycle is 21days) ]The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).
- the pharmacokinetic characteristics of HLX22 at different doses in patients. [ Time Frame: cycle1 to cycle 8 ,and 28-day follow-up visit after the last infusion (if possible),(each cycle is 21 days). ]Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses
- the pharmacodynamic characteristics of HLX22 at different doses in patients [ Time Frame: cycle 1 to cycle 6 (each cycle is 21 days) ]the concentration of soluble HER1 and HER2 in serum
- the immunogenicity of HLX22 in humans [ Time Frame: cycle 1 to cycle 6 (each cycle is 21 days) ]anti-HLX22 antibodies in serum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916094
|Contact: chaoming Ma||+86 firstname.lastname@example.org|
|Principal Investigator:||Yanhua Ding||First Hospital of Jilin University|