A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Официальное название

A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Обзор

This study is a open, multi-center phase II clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of SI-B001+SI-B003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.

Вмешательства

• Препарат SI-B001
  Administration by intravenous infusion
• Препарат SI-B003
  Administration by intravenous infusion

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (8)

• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Disease control rate (DCR) [Срок оценки: Up to approximately 24 months]
• Duration of response (DOR) [Срок оценки: Up to approximately 24 months]
• Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• Ctrough [Срок оценки: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with recurrent or metastatic head and neck squamous cell carcinoma;
• Consent to provide tumor tissue samples or fresh tissue samples archived from the primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• Physical status score: ECOG ≤1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• No blood transfusion or colony-stimulating factor was allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urinary protein ≤1+ or ≤1000mg/24h;
• Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Критерии исключения

• Squamous cell carcinoma of the nasopharynx, salivary gland, paranasal sinus, skin or of unknown primary site;
• Patients with any of the following conditions were not eligible for the study: a) suitable and willing for local treatment; b) received systemic therapy, excluding treatment for locally advanced disease as part of multimodal therapy;
• Patients with active central nervous system metastasis;
• Who had participated in any other clinical trial within 4 weeks before the study dose;
• Received radiotherapy within 4 weeks before the first dose of study drug;
• Use of traditional Chinese medicine with anti-tumor indications within 2 weeks;
• Had undergone major surgery within 4 weeks before the first dose;
• Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
• Pulmonary disease was defined as ≥ grade 3 according to NCI-CTCAE v5.0; Patients with existing or a history of interstitial lung disease (ILD);
• Have active infection requiring intravenous anti-infective therapy;
• Had received immunotherapy and had grade ≥3 irAE or grade ≥2 immune-related myocarditis;
• Received live attenuated vaccine within 4 weeks before the first dose of study drug;
• Had taken an immunomodulatory drug within 14 days before the first dose of study drug;
• Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• Other malignant tumors within 5 years before the first administration;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
• Poorly controlled hypertension;
• Patients with poor blood glucose control before the first dose;
• Had a history of severe cardiovascular and cerebrovascular diseases;
• Previous history of allogeneic stem cell, bone marrow or organ transplantation;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of SI-B001 or SI-B003;
• Had severe infusion reactions to antibody therapy in the past;
• Had autologous or allogeneic stem cell transplantation;
• Pregnant or lactating women;
• The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06668961 · SI-B001-SI-B003-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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