NCT05203601

A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor

Interventions

Type	Name	Description
BIOLOGICAL	SIBP-03	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.

Timeline

• Start date: 2020-11-26
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2022-01-24
• Last updated: 2023-12-27

Locations

1 site across 1 country: China