A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.
- Conditions
- Tumor
- Interventions
- Biological: SIBP-03
- Registration Number
- NCT05203601
- Lead Sponsor
- Shanghai Institute Of Biological Products
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SIBP-03(Recombinant anti-HER3 humanized monoclonal antibody injection) SIBP-03 Stage 1: dose escalation stage Injection, first dose 2mg/kg, then 5mg/kg until the dose are no longer met the requirements of continuing the trial or up to 40 mg/kg. Stage 2: joint extension stage: ① Group of advanced head and neck squamous cell carcinoma ：SIBP-03 \& Cetuximab 5mg/kg dose level: Sibp-03, 5 mg/kg, Q3W Cetuximab, 400 mg/m2 (week 1), 250 mg/m2 (weekly follow-up), QW 10mg/kg dose level: Sibp-03, 10 mg/kg, q3W Cetuximab, 400 mg/m2 (week 1), 250 mg/m2 (weekly follow-up), QW ② Group of breast cancer：SIBP-03 \& Trastuzumab \& Docetaxel 5mg/kg dose level: Sibp-03, 5 mg/kg, Q3W Trastuzumab, first dose 8 mg/kg, maintenance dose 6 mg/kg, q3w+ Docetaxel 75mg/m2 q3w. 10mg/kg dose level: Sibp-03, 10 mg/kg, q3W Trastuzumab, first dose 8 mg/kg, maintenance dose 6 mg/kg, q3w+ Docetaxel 75mg/m2 q3w.
- Primary Outcome Measures
Name Time Method CL（Clearance Rate） 28 days after the last dose Apparent volume of drug distribution removed from the body per unit time.
AE(Adverse Events) 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) 28 days after the last dose It shows the degree to which a drug is absorbed and used in the body.
Body temperature 28 days after the last dose Body temperature of the subject.
T ½（Terminal elimination half-life） 28 days after the last dose It reflects how quickly the drug is eliminated from the body.
SAE(Serious Adverse Events) 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) 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 28 days after the last dose Pulse rate of the subject.
Cmax(Peak Plasma Concentration) 28 days after the last dose It shows the highest plasma concentration of a drug that can be achieved after administration
Respiratory rate 28 days after the last dose Respiratory rate of the subject.
Blood pressure 28 days after the last dose Blood pressure of the subject.
- Secondary Outcome Measures
Name Time Method ADA(Anti-drug Antibody) The 1 day the test results reported after the last dose The incidence of anti-drug antibody.
NAb(Neutralizing Antibody) The 1 day the test results reported after the last dose The incidence of neutralizing antibody.
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China