A Study of SI-B036 in Patients With Locally Advanced or Metastatic Solid Tumors

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Solid Tumors

Обзор

This study is an open-label, multicenter, non-randomized Phase I clinical study of dose-escalation and expansion to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic solid tumors.

Подробное описание

The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).

Вмешательства

• Препарат SI-B036
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Phase Ia: Dose limiting toxicity (DLT) [Срок оценки: Up to 21 days after the first dose]
• Phase Ia: Maximum tolerated dose (MTD) [Срок оценки: Up to 21 days after the first dose]
• Phase Ib: Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (12)

• Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Objective Response Rate (ORR) [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]
• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• T1/2 [Срок оценки: Up to approximately 24 months]
• AUC0-t [Срок оценки: Up to approximately 24 months]
• CL (Clearance) [Срок оценки: Up to approximately 24 months]
• Ctrough [Срок оценки: Up to approximately 24 months]
• ADA (anti-drug antibody) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restriction;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Locally advanced or metastatic solid tumors;
• Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 2 years or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio ≤1.5, and Activated Partial Thromboplastin Time ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;
• The trial participant is capable and willing to adhere to the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.

Критерии исключения

• Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose;
• Receipt of immunosuppressive therapy within 2 weeks prior to the first dose;
• History of severe cardiac or cerebrovascular disease;
• QT interval prolongation, complete left bundle branch block, etc.;
• Active autoimmune diseases and inflammatory diseases;
• Prior experience of ≥ grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;
• Diagnosis of another solid tumor within 5 years prior to the first dose;
• Unstable thrombotic event requiring therapeutic intervention within 6 months prior to the first dose;
• Poorly controlled hypertension;
• Diabetic patients with poorly controlled blood glucose;
• History of ILD requiring steroid therapy, or current ILD, or ≥ grade 2 radiation pneumonitis;
• Concomitant pulmonary disease causing severe respiratory impairment;
• Active central nervous system metastases;
• History of allergy to recombinant humanized or human-mouse chimeric antibodies, or hypersensitivity to any excipient component of SI-B036;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug;
• Presence of pleural, abdominal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of study drug;
• Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;
• Study participants with clinically significant bleeding or a clear bleeding tendency within 4 weeks prior to screening;
• History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;
• Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
• Pregnant or breastfeeding women;
• Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical 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 · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07606612 · SI-B036-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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