PM8002 in the Treatment of Patients With Advanced Solid Tumors

Официальное название

Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors

Обзор

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.

Вмешательства

• Препарат PM8002
  IV infusion

Первичные конечные точки

• Number of participants with DLTs [Срок оценки: During the first three weeks of treatment with PM8002]
• Treatment related adverse events (TRAEs) [Срок оценки: Up to 30 days after last treatment]
• Objective response rate (ORR) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (5)

• Disease control rate (DCR) [Срок оценки: Up to approximately 2 years]
• Duration of response (DoR) [Срок оценки: Up to approximately 2 years]
• Overall survival (OS) [Срок оценки: Up to approximately 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to approximately 2 years]
• Anti-drug antibody (ADA) [Срок оценки: Up to 30 days after last treatment]

Критерии участия

Критерии включения

• Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
• Male or female aged 18 to 75 years;
• Patients with malignant tumor confirmed by histology or cytology;
• The toxicity of previous anti-tumor therapy has not been alleviated；
• Adequate organ function；
• ECOG score was 0-1;
• Expected survival >=12 weeks;
• According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.

Критерии исключения

• History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
• Evidence of major coagulopathy or other obvious risk of bleeding;
• Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
• Patients with uncontrolled brain metastases should be excluded from this clinical trial;
• Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
• Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
• Syphilis antibody positive;
• Patients with active tuberculosis (TB) are excluded;
• Pregnant or lactating women;
• Other conditions lead to inappropriate to participate in this study as judged by the investigator.

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 · 48 центров

• Baoji Central Hospital — Baoji
• Baoji Central Hospital — Baoji
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Peking University Cancer Hospital — Пекин
• Peking University Cancer Hospital — Пекин
• Jilin Cancer Hospital — Changchun
• The First Hospital of Jilin University — Changchun
• Changde First People's Hospital — Changde
• … и ещё 40 центров

Идентификаторы

NCT: NCT05918445 · PM8002-A001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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