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Набор скоро начнётся NCT07170787

A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors

Фаза I / Фаза II С лечением Advanced Solid Tumors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: IMM2510, IMM01.
Кому может быть актуально
Состояния в реестре: Advanced Solid Tumors. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors

Обзор

This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.

Вмешательства

  • Биопрепарат IMM2510
    IMM2510 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM2510 (e.g., 10 mg/kg, 20 mg/kg, up to maximum tolerated dose or recommended phase 2 dose).
  • Биопрепарат IMM01
    IMM01 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM01 (e.g., 1 mg/kg, 2 mg/kg, 3mg/kg, up to maximum tolerated dose or recommended phase 2 dose).

Первичные конечные точки

  • DLT/MTD (Dose Escalation Phase) [Срок оценки: Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)]
  • Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0) [Срок оценки: From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment]
  • Objective Response Rate (ORR) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • RP2D (Dose Extension Phase) [Срок оценки: From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 96 weeks]
Вторичные конечные точки (10)
  • Disease Control Rate(DCR) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • Duration of Response (DOR) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • progression- free survival(PFS) [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • overall survival（OS） [Срок оценки: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.]
  • Cmax [Срок оценки: Up to approximately 1 year]
  • Tmax [Срок оценки: Up to approximately 1 year]
  • AUC0-tlast [Срок оценки: Up to approximately 1 year]
  • AUC0-inf [Срок оценки: Up to approximately 1 year]
  • t1/2 [Срок оценки: Up to approximately 1 year]
  • CL [Срок оценки: Up to approximately 1 year]

Критерии участия

Критерии включения

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age greater than or equal to 18 years old at the same time of signing the informed consent.
  • Histologically or cytologically confirmed for Solid Tumor.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Adequate organ function as defined in protocol.

Критерии исключения

  • History of other malignancy within the past 5 years with exceptions.
  • Systemic chemotherapy was administered within 3 weeks prior to the first administration.
  • Activated symptomatic brain metastases and leptomeningeal disease.
  • History of inflammatory bowel disease.
  • Participants with symptoms and/or clinical signs and/or uncontrolled active systemic infection within 14 days prior to the first dose of study treatment.

Participant has known active infection requiring parenteral antibiotic treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Gobroad Cancer Hospital China Pharmaceutical University — Шанхай

Идентификаторы

NCT: NCT07170787 · ImmuneOncoBioShanghai

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗