Treatment of advanced head and neck cancer with SIBP-03

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)

This study is testing a new treatment called SIBP-03 for people with advanced head and neck cancer to see if it works better than a placebo and how safe it is.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, cetuximab
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06194656 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the safety and efficacy of SIBP-03, a HER3 monoclonal antibody, in patients with recurrent or metastatic advanced head and neck squamous cell carcinoma (HNSCC). The study is divided into two parts: Part Ⅱa is an open-label phase where participants receive different doses of SIBP-03 combined with cetuximab, while Part Ⅱb is a randomized, double-blind phase comparing the experimental group to a placebo control. Participants will be monitored for treatment response and any adverse effects throughout the 21-day treatment cycles until disease progression or other specified endpoints.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or metastatic advanced HNSCC who have previously failed immunotherapy and platinum-based treatments.

Not a fit: Patients who have not received prior anti-PD-1/anti-PD-L1 or platinum treatments, or those with nasopharyngeal carcinoma, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced head and neck cancer who have limited treatment alternatives.

How similar studies have performed: While there have been studies on HER3 monoclonal antibodies, this specific approach in advanced HNSCC is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* The subjects voluntarily participated in the study and signed the informed consent.
* Male and female aged between 18 and 75 years old, regardless of gender.
* Patients with recurrent/metastatic advanced HNSCC who have been diagnosed by histology or cytology, progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1 and platinum, and have no indication of radical local treatment. Subjects should not receive more than 2 lines of treatment in the past.
* During the screening period, subjects must provide tumor tissues and blood samples for biomarker detection. If the subject does not have an archived tumor tissue sample, he or she will undergo a fresh tumor biopsy during the screening period to obtain the corresponding tumor sample. If the subject can't provide archived or fresh tumor tissue samples, but can provide the previous test reports of qualified institutions, including all biomarker indicators specified in this scheme, they can be screened after communicating with the sponsor.
* There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 standard). Tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not measurable lesions unless the lesion has definite progression.
* The ECOG physical fitness score is 0-1.
* The laboratory test results meet the requirements.
* The expected survival time is ≥ 3 months.
* In fertile female subjects, the blood pregnancy test must be negative within 7 days before the first medication. Subjects of reproductive age (including male subjects) had no family planning during the trial period and within 6 months after the last administration and voluntarily took effective contraceptive measures.

Exclusion Criteria:

* The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses, nasopharynx and salivary gland.
* The participant has received any HER3 targeting or EGFR targeting therapy in the past.
* Active central nervous system metastasis and/or meningeal metastasis.
* Previous allergy to human normal immunoglobulin or antibody preparation or other serious infusion reaction; Severe hypersensitivity disease, allergic constitution.
* In the past 5 years, the subjects had suffered from malignant tumors other than those treated in this study (except cured thyroid cancer, skin basal cell carcinoma and cervical carcinoma in situ).
* People infected with active human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B vrius (HBV), syphilis or active tuberculosis, and asymptomatic chronic hepatitis B or hepatitis C carriers may be excluded.
* The subjects have not recovered from the toxicity of previous anti-tumor therapy to grade ≤ 1 or baseline level (except participants with hair loss, neuropathy of grade ≤ 2 or stabilized thyroid function's decline by hormon replacement therapy).
* Subjects are currently participating in and receiving research treatment or have been treated with other research drugs or medical devices within 4 weeks before the first use of research drugs.
* Patients who plan to receive any other anti-tumor treatment during the trial should be excluded.
* Major surgery, radiotherapy (except palliative radiotherapy for targeted bone metastasis), or treatment such as unhealed surgical wound, ulcer or fracture within 4 weeks before the first administration; Received Chinese patent medicines or Chinese herbal medicines with anti-tumor indications within 2 weeks before the first administration; Chemotherapy was received within 3 weeks before the first administration, and anti-tumor treatments such as biotherapy, endocrine therapy, targeted therapy and immunotherapy were received within 4 weeks
* Those who have been vaccinated live within 30 days before the first administration.
* Active infections requiring systemic treatment, such as pneumonia, bacteremia, septicemia, etc.
* A history of pulmonary interstitial disease, pulmonary interstitial fibrosis or drug-induced interstitial pneumonia or other clinically serious lung diseases (CTCAE 5.0 grade III-IV).
* Pulmonary thromboembolism, arterial thrombosis and deep vein thrombosis formation (DVT) occurred within 6 months before screening, except for infusion set-related thrombosis.
* Have a history or evidence of cardiovascular (CV) risk.
* During the screening period, 12-lead electrocardiogram (ECG) measurement was performed in the research center (the average value of QTcF that needs to be measured repeatedly for 3 times), and the QT interval (QTcF) corrected by Fridericia method was \> 450 milliseconds (male) or (QTcF) \> 470 milliseconds (female); LVEF of cardiac ultrasound was less than 50%.
* Therapeutic surgery was performed within 28 days before the first administration, or major surgery was expected during the study period (except diagnosis, biopsy and drainage).
* People with mental disorders or poor compliance.
* Pregnant or lactating women.
* According to the researcher's judgment, there are accompanying diseases (such as severe hypertension, diabetes, thyroid diseases, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.
* Suffering from diseases requiring long-term treatment with high doses (defined as 30mg/d hydrocortisone or equivalent doses of other hormonal drugs) of hormones or immunosuppressive drugs.
* After active treatment, uncontrollable pleural and abdominal cavity or other lacunar effusion.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ye Guo, Doctor — Shanghai Oriental Hospital
• Study coordinator: Dandan Chen, Master

Conditions Head and Neck Squamous Cell Carcinoma; Head and neck squamous cell carcinoma; safety; tolerability; pharmacokinetics; efficacy