CW-301 FIH Study of CAN016

Официальное название

A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors

Обзор

A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors

Подробное описание

This is a Phase I/II, Open-Label, Non-Randomized, Multi-centre First-in-Human Study.

Phase I:

Accelerated Titration Designs and 3+3 escalation design for MTD and/or RP2D determination.

Phase II:

Once the RP2D is determined, the study will enroll patients into Phase II. Approximately 20\~60 patients will be enrolled to evaluate the efficacy of CAN016 in HER2 expression or mutation advanced solid tumors.

Вмешательства

• Препарат CAN016
  CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
• Препарат CAN016
  an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1. A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed. Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD)

Первичные конечные точки

• Dose Limiting Toxicities (DLT) [Срок оценки: 12 months]
• Tumor objective response rate (ORR) [Срок оценки: 36 months]

Вторичные конечные точки (8)

• Safety and Tolerability [Срок оценки: 48 months]
• Pharmacokinetic measures - concentration time Area Under the Curves [Срок оценки: 12 months]
• Pharmacokinetic measures - Cmax [Срок оценки: 12 months]
• Pharmacokinetic measures - Tmax [Срок оценки: 12 months]
• Pharmacokinetic measures - terminal half- life (t1/2) [Срок оценки: 12 months]
• Pharmacokinetic measures - Vd [Срок оценки: 12 months]
• Pharmacokinetic measures - CL [Срок оценки: 12 months]
• Immunogenicity of CAN016 [Срок оценки: 48 months]

Критерии участия

Критерии включения

• Provide informed consent voluntarily
• Male or female patients ≥18 years of age.
• Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.

• For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;
• For Phase II, patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer, HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer and other HER2 expression or mutation advanced solid tumors are eligible. Patients must have had progression of disease on prior HER2 targeted ADC.
• At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Adequate organ function with 7 days before registration
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• LVEF ≥50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before registration.
• Life expectancy of ≥3 months.

Критерии исключения

• Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.
• Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
• Patients have autologous transplantation within 3 months.
• Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.
• Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.
• Any toxicities from prior treatment that have not recovered to baseline or ≤CTCAE Grade 1 before the start of study treatment, with exception of hair loss.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital Chinese Academy Of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07664150 · CW-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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