Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Cetuximab

Immunoglobulins

Immunologic Factors

Antineoplastic Agents, Immunological

Experimental group in part one. It will be 10mg/kg or 15mg/kg of SIBP-03. It will determine whether a 15mg/kg dose study is necessary based on actual research results.

Experimental group in part two. Its dose will be determined by results of study part one, and the tentative dose is 10mg/kg.

Placebo of SIBP-03 (SIBP-03 solvent without HER3 antibody), and the dose will be the same with group A.

10mg/kg or 15mg/kg, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

HER3 Monoclonal antibodies

Inject cetuximab every week, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time was 90 min (± 5 min).

Cetuximab injection

10mg/kg (provisional dosage) every three weeks, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time was 90 min (± 5 min).

Placebo

Dandan Chen, Master

Ye Guo, Doctor

This phase II study will be conducted in two parts at the same time, with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.

The participants in both study parts are the same, both of whom were patients with recurrent/metastatic advanced HNSCC (non nasopharyngeal carcinoma).

Part one is a one-arm, open-ended study. First, 3 subjects were treated with SIBP-03 15mg/kg every 3 weeks (Q3W) combined with cetuximab every week (QW). If 1/3 subjects (1 case) have DLT, 3 more subjects need to continue to observe the safety and tolerance; If DLT occurs in 3 cases or ≥ 2 cases in 6 cases, the sponsor and the researcher will discuss and decide whether to terminate this part of the study or change the dose. 12 subjects were added at most.

Part two is a randomized, double-blind study. Including a trial group and a placebo control group. The qualified subjects in this stage will be randomly assigned according to the ratio of 2: 1, including 38 cases in the experimental group and 19 cases in the control group, with a total of 57 subjects. Randomization was stratified according to ECOG scores (0 and 1) and stages (non-stage IV and stage IV).

Part one is a one-arm, open-ended study and part two is a randomized, double-blind study.

Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent/Metastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)

All subjects after receiving the investigational drug were observed during the trial for any AE that occurred during the clinical study.AE were manifested as symptoms, signs, diseases, or abnormal laboratory tests, but may not necessarily have a causal relationship with the investigational drug.

That is serious adverse events, any serious adverse events that occurred to the subject during the study period.

It shows the highest plasma concentration of a drug that can be achieved after administration.

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.

It reflects how quickly the drug is eliminated from the body.

Apparent volume of drug distribution removed from the body per unit time.

Differences in ORR between SIBP-03 and placebo evaluated by the Independent Evaluation Committee (IRC) according to RECIST 1.1. Only applicable to part two.

The proportion of subjects whose tumor volume shrinks to a predetermined value and maintains the minimum time limit, and is the sum of complete and partial responses.

In clinical trials, the percentage of subjects with advanced or metastatic cancer who responded fully to cancer treatment, partially responded, and had stable disease.

The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).

Spots Global Cancer Trial Database for her3 monoclonal antibodies