A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.
Condition: Tumor
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): SIBP-03
Intervention type(s): Biological
Intervention description(s): Stage 1:
Six dose groups of 2, 5, 10, 15, 20 and 40 mg/kg were planned. Dose increments began at 2 mg/kg using accelerated titration. In the first dose group, after the first patient was injected with Sibp-03, if the subject developed toxicity grade ≥2（CTCAE v5.0 standard）within 21 days of initial administration，then the subject increased to 3 and the study design method in this dose level convert to "3+3". If the subject didn't develop toxicity grade ≥2, then the study of the second and next dose group can be carried out using "3+3" incremental design.
Stage 2:
Cohort 1 included patients with advanced head and neck squamous cell carcinoma and cohort 2 included patients with breast cancer. According to the results of dose escalation stage and similar drug trials, 5mg/kg and 10mg/kg dose levels were selected to enter this phase. Each cohort will be extended to include 6-8 subjects to receive this product in combination with the standard treatment study.
Intervention model: Single Group Assignment
Intervention model description: This is a dose escalation and extension study which designed as an open and multi-dose escalation study with single and multiple dosing.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Monoclonal antibody; HER3; safety; efficacy; pharmacokinetics