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

NCT05203601 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-12-27

No results posted yet for this study

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.

Conditions

  • Tumor

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Co., Ltd Shanghai Institute Of Biological Products · Shanghai Institute Of Biological Products

  • Shanghai Cancer Center Fudan University · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-12-06
Completion
2022-12-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203601 on ClinicalTrials.gov