This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of LDP in subjects with advanced malignant tumors.
This trial is an open, dose escalation phase I clinical trial study of patients with advanced cancer who have failed standard treatment. The trial is divided into a dose escalation phase and an expansion phase. Approximately 130 patients will be enrolled in this trial. The dose-increasing phase is about 30 cases, and the expansion stage is about 100 cases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Dose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
Number of participants with dose limiting toxicity (DLT)
An DLT is defined as a ≥Grade 3 drug-related adverse event occurring within the first cycle (28 days) of dosing (excluding tumor flare causing local pain at sites of known or suspected tumor, localized rash, or a transient ≤Grade 3 infusion reaction) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: At the end of Cycle 1 (28 days).
Maximum tolerable dose (MTD)
MTD refers to the highest dose which can satisfy the first cycle of the same dose group and the proportion of DLT occurring is less than 1/3 in the incremental dose stage. The dose of MTD required confirmation by 6 subjects.
Time frame: At the end of Cycle 1 (28 days).
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of LDP After Infusion
Pharmacokinetic parameters Cmax for LDP
Time frame: Up to 22 Days
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion AUC(0-t) for LDP
AUC(0-t) for LDP
Time frame: Up to 22 Days
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion Pharmacokinetic parameters: AUC(0-00) for LDP
Pharmacokinetic parameters: AUC(0-00) for LDP
Time frame: Up to 22 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of LDP After Infusion
Pharmacokinetic parameters T1/2 for LDP
Time frame: Up to 22 Days
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Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)
Immunogenicity indicators: Number of participants with positive anti-drug
Time frame: Up to 176 Days
Immunogenicity indicators: Number of participants with positive neutralizing antibodies
Immunogenicity indicators: Number of participants with positive neutralizing antibodies
Time frame: Up to 176 Days
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 through 21 days after last dose of LDP up to 2 years.
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with LDP until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: From first dose of LDP through 21 days after last dose of LDP up to 2 years.