Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

Официальное название

A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors

Обзор

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.

Вмешательства

• Препарат FH-006
  Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days
• Препарат FH-006
  administered once every 3 weeks (Q3W), with a treatment period of 21 days

Первичные конечные точки

• DLT: 21or28 days after the first administration of each subject [Срок оценки: 21or28 days after the first administration of each subject]
• AE: from Day1 to 30 days after last dose [Срок оценки: from Day1 to 30 days after last dose]
• Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose [Срок оценки: from Day1 to 30 days after last dose]
• MTD or MAD： 21 or 28 days after the first dose of medication for each subject on dose escalation stage [Срок оценки: 21 or 28 days after the first dose of medication for each subject on dose escalation stage]
• RP2D：Obtain two treatment evaluation data for the last subject during the dose expansion phase [Срок оценки: Obtain two treatment evaluation data for the last subject during the dose expansion phase]

Вторичные конечные точки (1)

• Immunogenic indicators: anti-FH-006 antibody (ADA) [Срок оценки: through study completion, an average of 2 years]

Критерии участия

Критерии включения

• Women aged 18 to 75 (inclusive)
• Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.
• ECOG score is 0 or 1
• An expected survival of ≥3 months
• At least one target lesion according to RECIST v1.1 criteria
• Has a good level of organ function
• Patients voluntarily joined the study and signed informed consent

Критерии исключения

• Have other malignancies within the past 5 years
• Active central nervous system metastasis without surgery or radiotherapy
• Presence with uncontrollable third space effusion
• Have undergone other anti-tumor treatment within 4 weeks before the first dose
• Has severe infection within 4 weeks before the first medication
• Any active autoimmune disease or a history of autoimmune disease
• A history of immune deficiency
• Has serious cardiovascular and cerebrovascular diseases
• Clinically significant history of lung disease
• The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
• Having undergone surgery on important organs within 4 weeks prior to the first use of medication
• Used attenuated live vaccine within 28 days prior to the first use of the investigational drug
• Presence of other serious physical or mental diseases or laboratory abnormalities

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06735144 · FH-006-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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