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

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)

• ClinicalTrials.gov (NIH, США)

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