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

NCT06194656 | Recruiting Phase 2 DMC

• 1 other identifier: SIBP-03-02
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief 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

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck squamous cell carcinoma; safety; tolerability; pharmacokinetics; efficacy

Outcome Measures

Primary Outcomes (7)

• The occurrence of any adverse events (AE)

  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.

  30 days after the last dose

• SAE (Serious Adverse Events)

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

  30 days after the last dose

• Cmax (Peak Plasma Concentration)

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

  30 days after the last dose

• Tmax(Peak Time)

  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.

  30 days after the last dose

• T ½(Terminal elimination half-life)

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

  30 days after the last dose

• CL(Clearance Rate)

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

  30 days after the last dose

• Difference of ORR

  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 1 day the test results reported after the last dose

Secondary Outcomes (5)

• ORR (Objective Response Rate)

  The 1 day the test results reported after the last dose

• DCR (Disease control rate)

  The 1 day the test results reported after the last dose

• PFS (Progression-free survival)

  The 1 day the test results reported after the last dose

• ADA (Anti-drug Antibody)

  The 1 day the test results reported after the last dose

• NAb (Neutralizing Antibody)

  The 1 day the test results reported after the last dose

Study Arms (5)

Group A

EXPERIMENTAL

Experimental group in Ⅱa (part one). It will be the dose A of SIBP-03. It will determine whether the dose A is the optimal recommended dosage (RP2D) based on actual study results.

Drug: HER3 Monoclonal antibodies-Dose A; Combination Product: Cetuximab injection

Group B

EXPERIMENTAL

Experimental group in Ⅱa (part one). It will be the dose B of SIBP-03. It will determine whether the dose B is the RP2D based on actual study results.

Drug: HER3 Monoclonal antibodies-Dose B; Combination Product: Cetuximab injection

Group C

EXPERIMENTAL

Experimental group in Ⅱa (part two). It will be the dose C of SIBP-03. It will determine whether the dose C is the RP2D based on actual study results.

Drug: HER3 Monoclonal antibodies-Dose C; Combination Product: Cetuximab injection

Group D

EXPERIMENTAL

Experimental group in Ⅱb. It will be the RP2D of SIBP-03.

Other: HER3 Monoclonal antibodies-Dose D; Combination Product: Cetuximab injection

Group E

PLACEBO COMPARATOR

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

Other: Placebo; Combination Product: Cetuximab injection

Interventions

Placebo OTHER

SIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks, 21 days as a cycle.

Group E

Cetuximab injection COMBINATION_PRODUCT

Medications used for combination therapy, intravenous infusion (IV). Administer once a week.

Group A; Group B; Group C; Group D; Group E

HER3 Monoclonal antibodies-Dose A DRUG

Dose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

Group A

HER3 Monoclonal antibodies-Dose B DRUG

Dose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

Group B

HER3 Monoclonal antibodies-Dose C DRUG

Dose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

Group C

HER3 Monoclonal antibodies-Dose D OTHER

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).

Group D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (2)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ye Guo, Doctor

  Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Chen, Master

CONTACT

86-021-62800991; ddchen.sh@sinopharm.com

Ye Guo, Doctor

CONTACT

86-13501678472; pattrickguo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ⅱa is an open-label study and Ⅱb is a randomized, double-blind study.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)