A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors

Официальное название

A Phase Ib/II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

Обзор

This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.

Вмешательства

• Препарат SHR-4375 Injection
  SHR-4375 injection in combination with other antitumor therapies.

Первичные конечные точки

• Dose limiting toxicity (DLT). [Срок оценки: 3 weeks.]
• Recommended phase II dose (RP2D). [Срок оценки: From screening period up to study completion, an average of 1 year.]
• Adverse events (AEs). [Срок оценки: From screening period up to study completion, an average of 1 year.]
• Objective response rate (ORR). [Срок оценки: From screening period up to study completion, an average of 1 year.]

Вторичные конечные точки (4)

• Disease control rate (DCR) [Срок оценки: From screening period up to study completion, an average of 1 year.]
• Duration of response (DoR) [Срок оценки: From screening period up to study completion, an average of 1 year.]
• Progression-free survival (PFS) [Срок оценки: From screening period up to study completion, an average of 1 year.]
• Drug Resistant Antibody (ADA) to SHR-4375 [Срок оценки: From screening period up to study completion, an average of 1 year.]

Критерии участия

Критерии включения

• Voluntary participation and written informed consent.
• 18-75 years older, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 12 weeks.
• Patients with advanced solid tumors confirmed by cytology or histology who have failed or are intolerant to standard treatment and have no standard treatment.
• Be able to provide fresh or archived tumour tissue.
• At least one measurable lesion according to RECIST v1.1.
• Adequate bone marrow and organ function.
• Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Критерии исключения

• There are components of neuroendocrine carcinoma or sarcoma in the histopathological type.
• Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
• Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
• Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration.
• Previously received antibody-drug conjugate therapy containing topoisomerase I inhibitors.
• Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study.
• Suffering from other active malignant tumors within 3 years or at the same time.
• Symptomatic or active central nervous system tumor metastasis.
• Accompanied by uncontrolled tumor related pain.
• Subjects who have experienced severe infections within 30 days prior to their first medication use.
• History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past.
• AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1.
• Active hepatitis B or active hepatitis C.
• Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication.
• Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
• Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
• Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

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

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07298772 · SHR-4375-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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