NCT06194656

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II study will be conducted in two parts (Ⅱa and Ⅱb), 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.

Detailed description

This phase II study will be conducted in two parts (Ⅱa and Ⅱb), 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). * a is an open-label study. Part one, 12 subjects were randomly assigned 1:1 to two groups and treated with SIBP-03 dose A or dose B every 3 weeks (Q3W) combined with cetuximab every week (QW). Part two, 3 subjects were treated with SIBP-03 dose C Q3W combined with cetuximab 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. * b is a randomized, double-blind study. Including an experimental group (RP2D) 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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HER3 Monoclonal antibodies-Dose A	Dose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
DRUG	HER3 Monoclonal antibodies-Dose B	Dose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
DRUG	HER3 Monoclonal antibodies-Dose C	Dose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
OTHER	HER3 Monoclonal antibodies-Dose D	The optimal recommended dosage (RP2D) of SIBP-03intravenous, infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
OTHER	Placebo	SIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks, 21 days as a cycle.
COMBINATION_PRODUCT	Cetuximab injection	Medications used for combination therapy, intravenous infusion (IV). Administer once a week.

Timeline

• Start date: 2024-09-27
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2024-01-08
• Last updated: 2026-01-16

Locations

2 sites across 1 country: China