Study of CM518D1 in Patients With Advanced Solid Tumors

Официальное название

A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors

Обзор

This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.

Вмешательства

• Биопрепарат CM518D1
  CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.
• Биопрепарат CM518D1
  CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).
• Биопрепарат CM518D1
  CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.

Первичные конечные точки

• Dose Limiting Toxicity (DLT)-Phase I dose escalation [Срок оценки: First cycle (21 days)]
• Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation [Срок оценки: Through study completion, an average of 2 years.]
• Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion [Срок оценки: Through study completion, an average of 2 years.]]
• Preliminary efficacy-Phase I dose expansion [Срок оценки: Through study completion, an average of 2 years.]]
• Objective response rate (ORR)-Phase II [Срок оценки: Through study completion, an average of 2 years.]]

Критерии участия

Критерии включения

• 1\. Male or female ≥ 18 and ≤75 years of age.
• 2\. Subjects with histologically or cytologically confirmed advanced solid tumors.
• 3\. At least one measurable lesion according to RECIST v1.1.
• 4\. Expected survival time ≥ 3 months as judged by the Investigator.

Критерии исключения

• 1\. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).
• 2\. Subjects who have received major surgery within 28 days prior to the first dose.
• 3\. Subjects who have received radiotherapy within 21 days prior to the first dose.
• 4\. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.
• 5\. Subjects who have received any CDH17-targeted therapy.
• 6\. History of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ.
• 7\. Hypersensitivity to the investigational drug or its excipients.
• 8\. Pregnant or lactating female patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center (SYSUCC) — Гуанчжоу

Идентификаторы

NCT: NCT07019779 · CM518D1-030101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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