A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

Официальное название

A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions/Rearrangements Who Have Failed Prior Therapy

Обзор

This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy

Вмешательства

• Препарат ICP-192
  ICP-192 is a round, uncoated tablet, 5mg, orally.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: Up to 3 years]

Вторичные конечные точки (12)

• Progression-free survival (PFS) [Срок оценки: Up to 3 years]
• Disease control rate (DCR) [Срок оценки: Up to 3 years]
• Duration of response (DOR) [Срок оценки: Up to 3 years]
• Time to response (TTR) [Срок оценки: Up to 3 years]
• Overall survival (OS) [Срок оценки: Up to 3 years]
• The adverse event (AE) of ICP-192 assessed by NCI-CTCAE V5.0 [Срок оценки: Up to 3 years]
• Maximum concentration (Cmax) [Срок оценки: Up to 3 years]
• Time to maximum concentration (Tmax) [Срок оценки: Up to 3 years]
• Half-life (T1/2) [Срок оценки: Up to 3 years]
• Area under the concentration-time curve (AUC) [Срок оценки: Up to 3 years]
• Apparent clearance (CL/F) [Срок оценки: Up to 3 years]
• Terminal apparent volume of distribution (Vz/F) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Signed the ICF and Age ≥ 18 years old, either sex.
• ECOG score of 0-1.
• Life expectancy > 3 months.
• Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV) tumor that has progressed following at least one line of chemotherapy and progression/recurrence within 6 months after neoadjuvant/adjuvant chemotherapy may be included.
• FGFR2 fusion /rearrangement as confirmed by the central laboratory.
• At least one measurable lesion at screening as target lesion per RECIST 1.1.
• Organ functions meeting the protocol requirements.
• Contraception according to the protocol requirements.

Критерии исключения

• Presence of other malignancies requiring medical intervention.
• Prior treatment with selective FGFR inhibitors or FGFR antibodies.
• Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3 weeks prior to the first dose of study drug.
• Known symptomatic central nervous system (CNS) metastases.
• Patients who have not recovered from the toxicity caused by previous anti-tumor treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0 evaluation criterion) at the first dose of study drug.
• Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.
• Any unstable or uncontrolled systemic disease as judged by the investigator, such as: active infection requiring intravenous therapy, uncontrolled hypertension (After treatment systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg), and diabetes mellitus (HbA1c > 8%).
• Current active bleeding, such as deep venous thrombosis, portal hypertension signs leading to gastroesophageal venous bleeding.
• Wound with active infection.
• Major surgical procedures within 4 weeks prior to the first dose of the study drug or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
• Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity
• History and/or current evidence of extensive tissue calcification, including but not limited to calcification in soft tissues, kidney, intestine, myocardium, vasculature and/or the lungs, with the exception of lymph node calcification, mild pulmonary parenchymal calcification, and asymptomatic coronary artery calcification.
• Clinically serious gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug (such as poorly controlled nausea, vomiting, diarrhea; malabsorption syndrome; intestinal obstruction and small bowel resection, etc.), or the patient was unable to swallow the drug orally.
• Active HBV infection, Active HCV infection, HIV infection.
• Female subjects who are pregnant or breastfeeding, or plan to have a pregnancy within 6 months after the last dose of the study drug; or male subjects who plan to father a child during the study or within 6 months after the last dose of the study drug.
• The last dose of strong CYP3A inhibitor or CYP3A inducer (including food, western medicine, traditional Chinese medicine) is less than 5 half-lives before the first dose of study drug, or plans to take concomitant drugs or foods with strong CYP3A inhibition or induction during the study.
• Known allergy to any excipients of the study drug.
• Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.

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 · 44 центра

• Anhui Provincial Hospital — Хэфэй
• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин
• Peking Union Medical College Hospital — Пекин
• Beijing Youan Hosptital,Capital Medical University — Пекин
• Beijing Cancer Hospital — Пекин
• Beijing Hospital — Пекин
• Fujian Cancer Hospital — Fujian
• Fujian Medical University Union Hospital — Фучжоу
• … и ещё 36 центров

Идентификаторы

NCT: NCT05678270 · ICP-CL-00305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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