A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Официальное название

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Обзор

Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.

Подробное описание

Phase II: To explore the efficacy of BL-B01D1+SI-B003 combination in patients with locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma. To explore the safety and tolerability of BL-B01D1+SI-B003 combination in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.

Вмешательства

• Препарат BL-B01D1
  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]
• Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (4)

• 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]

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 histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;
• Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 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, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the level of organ function must meet the requirements;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• For stage 3 Cohort\_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent;
• Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
• Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
• Use of immunomodulatory drugs within 14 days before the first dose of study drug;
• History of severe heart disease;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block;
• Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
• Active autoimmune and inflammatory diseases;
• Other malignancies diagnosed within 5 years before the first dose;
• Hypertension poorly controlled by two antihypertensive drugs;
• Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients with current or history of ILD;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or within 4 weeks before signing informed consent;
• Patients with active central nervous system metastases;
• Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of the test drug;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
• Active infection requiring systemic therapy;
• Had participated in another clinical trial within 4 weeks before the first dose;
• The investigator did not consider it appropriate to use other conditions 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 16 центров

• Chongqing University Cancer Hospital — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Liuzhou People's Hospital — Liuzhou
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• Henan Cancer Hospital — Чжэнчжоу
• … и ещё 8 центров

Идентификаторы

NCT: NCT05956587 · BL-B01D1-SI-B003-201-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗