Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer

Официальное название

A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer

Обзор

This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.

Вмешательства

• Препарат GFH375
  The experimental group receives GFH375 monotherapy, QD, orally
• Препарат Chemotherapy
  The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.

Первичные конечные точки

• OS [Срок оценки: Up to approximately 2 years]
• PFS [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (9)

• PFS [Срок оценки: Up to approximately 2 years]
• ORR [Срок оценки: Up to approximately 2 years]
• DCR [Срок оценки: Up to approximately 2 years]
• DoR [Срок оценки: Up to approximately 2 years]
• TTR [Срок оценки: Up to approximately 2 years]
• The incidence and severity of AEs and SAEs [Срок оценки: Up to approximately 2 years]
• EORTC QLQ-C30 Score [Срок оценки: Up to approximately 2 years]
• EORTC QLQ-PAN26 Score [Срок оценки: Up to approximately 2 years]
• Plasma concentrations of GFH375 [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Voluntarily participate in the study and sign the informed consent form.
• Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.
• Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.
• Have received at least one prior standard systemic therapy.
• Participants must have at least one measurable lesion (per RECIST 1.1 criteria).
• Expected survival time ≥ 12 weeks as judged by the investigator.
• Have adequate organ function

Критерии исключения

• Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
• With active central nervous system (CNS) metastasis.
• Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.
• Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.
• Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.
• With clinically significant severe cardiovascular diseases.
• Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.
• Complicated with major acute or chronic infectious diseases.
• Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.
• Pregnant or lactating females.
• Other conditions deemed inappropriate for participation in the study by the investigator.

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

• Peking University Cancer Hospital & Institute — Пекин

Идентификаторы

NCT: NCT07262567 · GFH375X1301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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