MedTrace Logo

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

NCT06194656 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Ye Guo, Doctor · Shanghai Oriental Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06194656 on ClinicalTrials.gov