This is an exploratory clinical study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in patients with advanced malignant tumor.
This is an open, dose-escalation and dose-extension exploratory clinical study for patients with advanced malignancy who have failed standard therapy. In the dose-escalation phase, a fixed dose of CDP1 will be given once a week, while LDP will be given every two weeks with dose climbing. Then, cohort studies (cohorts 1 to 5) will be conducted during the dose-expansion phase. The purpose is to preliminarily evaluate the safety and efficacy of LDP combined with CDP1 in the treatment of patients with advanced malignant tumor, and to determine the recommended dose for clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
In the dose-escalation phase, CDP1 400 mg/ m2 will be given in the first week, then 250 mg/m2 will be given evert week. LDP will be given every two weeks with dose climbing of 5 mg/kg, 10 mg/kg, 20 mg/kg. Dose in the dose-expansion phase according to the assesment in the dose-escalation phase.
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
Incidence of adverse events
Adverse events (AEs) refer to all adverse medical events that occur when subjects sign the informed consent, which may be manifested as symptoms, signs, diseases or abnormal laboratory tests, but not necessarily causally related to the investigational drug.
Time frame: From first dose of LDP combined of CDP1 through 30 days after last dose, up to 5 months.
Dose Limiting Toxicities (DLT)
Number of participants with dose limiting toxicity (DLT)
Time frame: Time Frame: 28 days after first dose of LDP combined of CDP1, up to 24 months.
Recommended dose for clinical trials
A comprehensive evaluation of the results from the dose escalation/expansion phase was conducted to determine the recommended dose for the clinical trial.
Time frame: up to 24 months
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Time frame: From first dose of LDP combined of CDP1, up to 2 years.
Duration of response (DOR)
The duration of response (DOR) is defined as the time from the beginning of the first tumor assessment as PR or CR to the first assessment as PD or death from any cause.
Time frame: From first dose of LDP combined of CDP1, an average of 6 months.
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of the optimal time response of CR, PR, disease stable (SD) (i.e. CR+PR+SD) between initiation of the trial drug and withdrawal from the trial, as assessed according to RECIST1.1 criteria
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Time frame: From first dose of LDP combined of CDP1, up to 2 years.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time elapsed from the day the study drug was first administered until the first imaging assessment of disease progression (PD) or death from any cause.
Time frame: From first dose of LDP combined of CDP1, an average of 6 months.
Maximum plasma concentrations (Cmax)
Pharmacokinetic parameter, Observed Maximum Serum Concentration (Cmax) of LDP and CDP1.
Time frame: an average of 6 months
Area under the plasma concentration-time curve from zero to last concentration time (AUC0-t)
Pharmacokinetic Parameters, Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of LDP and CDP1.
Time frame: an average of 6 months
Half-life (t1/2)
Pharmacokinetic parameters,Apparent Terminal Half-life (t1/2) of LDP and CDP1.
Time frame: an average of 6 months
anti-drug antibody (ADA)
Anti-drug antibody (ADA) is tested for immunogenicity assessment , titer and neutralizing antibody analysis were performed when ADA was positive, and immunocomplex (CIC) and complement analysis were performed.
Time frame: an average of 6 months