First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors

Обзор

This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.

Вмешательства

• Препарат 7MW4911
  7MW4911 for IV infusion of various dose strengths administered

Первичные конечные точки

• Incidence and rates of adverse events [Срок оценки: Up to approximately 2 years]
• Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (RP2D) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (7)

• Objective response rate [Срок оценки: Up to approximately 2 years]
• Progression-free survival [Срок оценки: Up to approximately 2 years]
• Immunogenicity [Срок оценки: Up to approximately 2 years]
• Tmax [Срок оценки: Up to 3 months]
• Cmax [Срок оценки: Up to 3 months]
• t1/2 [Срок оценки: Up to 3 months]
• Area under the curve [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

• Aged 18\~75.
• ECOG 0-1.
• Life expectancy ≥ 3 months.
• Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
• Disease progression after the most recent treatment regimen.
• At least one measurable lesion according to RECIST v1.1.
• Provision of archival tumor tissue or fresh biopsy.
• Adequte hematologic funciton, liver function and renal function.
• Comply with contraceptive requirements.

Критерии исключения

• Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
• Active, untreated or symptomatic CNS metastasis.
• Effusions that require frequent drainage.
• Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
• Severe respiratory disease that required hospitalization in the last 28 days.
• Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration.
• Poorly controlled blood glucose with fasting blood glucose above 10 mmol/L.
• Recipient of allogeneic stem cell transplant or organ transplant
• Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
• Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
• Prohibited treatment and treatment that requires washout period: (1) Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy. (2) Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration. (3) Major surgeries within 28 days prior to study drug administration. (4) Investigational therapy within 28 days prior to study drug administration. (5) Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed. (6) Use of strong CYP3A4 inhibitor or inducer.
• Known hypersensitivity to 7MW4911 or components of the formulation.
• Abuse of narcotic or psychoactive drugs.
• Pregnant or breastfeeding women.
• Other circumstances or conditions where the investigator judges to be unsuitable for study.

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: NCT07265622 · 7MW4911-CP102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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