A Phase Ⅰa Clinical Study Exploring Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tumor
- Sponsor
- Shanghai Institute Of Biological Products
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- CL（Clearance Rate）
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The main purpose of
• To evaluate the safety, tolerability and pharmacokinetic characteristics of SIBP-03（Recombinant anti-HER3 humanized monoclonal antibody injection）.
A secondary purpose
- Assess the immunogenicity of SIBP-03. Exploratory purpose
- Explore potential biomarkers;
- Preliminary evaluation of the antitumor efficacy of SIBP-03.
Detailed Description
To evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of recombinant anti-HER3 humanized monoclonal antibody injection when treating the patients with advanced malignant solid tumors. This study is an open, multi-dose escalation and extension study of single and multiple dosing. This study was divided into two phases: the first phase was dose escalation phase, the second phase was joint expansion phase, in which the dose escalation phase was a single-center study, and the joint expansion phase was a multi-center study. Stage 1, dose escalation stage: Six dose groups of 2, 5, 10, 15, 20 and 40 mg/kg were planned, then exploring the most appropriate dose. The second stage, combined use extension stage: According to the preliminary data of drug safety, tolerance, pharmacokinetics and efficacy obtained in the dose escalation stage, combined with the clinical study results of similar drugs, 5mg/kg and 10mg/kg dose levels were selected to enter the combined extension stage and used in patients with advanced head and neck squamous cell carcinoma or with breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
CL（Clearance Rate）
Time Frame: 28 days after the last dose
Apparent volume of drug distribution removed from the body per unit time.
AE(Adverse Events)
Time Frame: 28 days after the last dose
That is adverse events, any adverse events that occurred to the subject during the study period.
AUC(Area Under The Plasma Concentration Versus Time Curve)
Time Frame: 28 days after the last dose
It shows the degree to which a drug is absorbed and used in the body.
Body temperature
Time Frame: 28 days after the last dose
Body temperature of the subject.
T ½（Terminal elimination half-life）
Time Frame: 28 days after the last dose
It reflects how quickly the drug is eliminated from the body.
SAE(Serious Adverse Events)
Time Frame: 28 days after the last dose
That is serious adverse events, any serious adverse events that occurred to the subject during the study period.
Tmax(Peak Time)
Time Frame: 28 days after the last dose
That is peak time of drug action, it shows the time required to reach the maximum concentration on the subject plasma concentration curve after administration.
Pulse rate
Time Frame: 28 days after the last dose
Pulse rate of the subject.
Cmax(Peak Plasma Concentration)
Time Frame: 28 days after the last dose
It shows the highest plasma concentration of a drug that can be achieved after administration
Respiratory rate
Time Frame: 28 days after the last dose
Respiratory rate of the subject.
Blood pressure
Time Frame: 28 days after the last dose
Blood pressure of the subject.
Secondary Outcomes
- ADA(Anti-drug Antibody)(The 1 day the test results reported after the last dose)
- NAb(Neutralizing Antibody)(The 1 day the test results reported after the last dose)