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

Официальное название

An Open-Label, Multi-center Phase 1/2 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.

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 (12)

• Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months))]
• Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months))]
• Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months))]
• Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months))]
• Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months))]
• Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. [Срок оценки: Initiation of study drug until study discontinuation, (up to approximately 24 months))]
• Duration of Response (DOR) as assessed by RECIST v1.1 [Срок оценки: Up to 45 months]
• Disease control rate (DCR) 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 (OS) [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]

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.
• Assessed by the investigator to be unsuitable for participation in this study.

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 · 2 центра

• Beijing Cancer Hospital — Пекин
• ZhongShan Hospital — Шанхай

Идентификаторы

NCT: NCT06378593 · 3HP-2827-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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