A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors

Официальное название

A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors

Обзор

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.

Вмешательства

• Препарат SHR-3276
  Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset. Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. Indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Первичные конечные точки

• Incidence and severity of adverse events [Срок оценки: up to 3 years]
• MTD [Срок оценки: up to 6 months]
• RP2D [Срок оценки: up to 1 year]

Вторичные конечные точки (9)

• Time to maximum concentration (Tmax) [Срок оценки: up to 3 years]
• Maximum concentration (Cmax) [Срок оценки: up to 3 years]
• Receptor Occupancy（OR） of SHR-3276 [Срок оценки: up to 3 years]
• Anti-drug antibody (ADA) of SHR-3276 [Срок оценки: up to 3 years]
• Objective response rate (ORR) [Срок оценки: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
• Duration of response (DoR) [Срок оценки: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
• Disease control rate (DCR) [Срок оценки: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
• Progression free survival（PFS） [Срок оценки: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
• Overall survival (OS) [Срок оценки: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]

Критерии участия

Критерии включения

• Able and willing to sign a written informed consent；
• Age 18-70 years old (including both ends), both male and female；
• Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
• Existence of measurable lesions；
• ECOG score: 0-1；
• Expected survival time ≥ 12 weeks；
• The functional level of the major organs must meet the requirements；
• Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

Критерии исключения

• Central nervous system metastasis or meningeal metastasis with clinical symptoms;
• Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
• Patients with uncontrolled tumor-related pain as judged by the investigator
• A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
• Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
• Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
• Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
• Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
• Systemic immunosuppressive therapy was administered within 14 days prior to the first study
• Arterial/venous thrombosis events occurred within 3 months prior to initial administration
• Patients with clinical significant lung disease;
• Patients with history of autoimmune diseases;
• The first study studied any other malignancy within 5 years prior to medication
• A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
• Have a history of immune deficiency or organ transplantation；
• Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

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

• The Second Affiliated Hospital of PLA Army Medical University — Чунцин

Идентификаторы

NCT: NCT06643754 · SHR-3276-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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