A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

Официальное название

A First-in-human, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

Обзор

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).

Вмешательства

• Препарат 3HP-2827
  3HP-2827 will be administered orally once daily in 28-day cycles.

Первичные конечные точки

• Dose Escalation Stage- incidence of adverse events (AEs) [Срок оценки: From baseline up until 28 days after the final dose]
• Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) [Срок оценки: Days 1-28 of Cycle 1 (a cycle is 28 days)]
• Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs [Срок оценки: From baseline up until 28 days after the final dose]
• Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [Срок оценки: From baseline up until 28 days after the final dose]
• Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [Срок оценки: From baseline up until 28 days after the final dose]
• Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months)]
• Expansion stage -Objective response rate（ORR） [Срок оценки: Initiation of study drug until disease progression (up to approximately 36 months)]

Вторичные конечные точки (9)

• Plasma Concentration of 3HP-2827 and/or its major metabolites [Срок оценки: Initiation of study drug until study discontinuation（up to 45 months）]
• Duration of Response (DOR) as assessed by RECIST v1.1 [Срок оценки: Up to 45 months]
• Progression-free survival (PFS) as assessed by RECIST v1.1 [Срок оценки: Up to 45 months]
• Overall survival [Срок оценки: Up to 48 months]
• Dose escalation stage - Objective Response Rate (ORR) [Срок оценки: Up to 45 months]
• Expansion Stage- incidence of adverse events (AEs) [Срок оценки: From baseline up until 28 days after the final dose]
• Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs [Срок оценки: From baseline up until 28 days after the final dose]
• Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [Срок оценки: From baseline up until 28 days after the final dose]
• Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [Срок оценки: From baseline up until 28 days after the final dose]

Критерии участия

Критерии включения

• The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol
• Men or women, age ≥ 18 years at the time of signing informed consent.
• Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.
• ECOG score is 0 or 1.
• An expected survival of ≥ 12 weeks.
• Evaluable or measurable disease per RECIST v1.1.
• Adequate organ function, as measured by laboratory values.

Критерии исключения

• Active brain metastases.
• Have other malignancies within the past 3 years.
• The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.
• Clinically significant corneal or retinal disease/keratopathy.
• Clinically significant cardiovascular disorders.
• Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption.
• Known to be allergic to any study drug or any of its excipients.
• Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.

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

США · 2 центра

• Mayo Clinic — Phoenix
• The University of Texas MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06287918 · 3HP-2827-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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