A Study of KNT-0916 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

Официальное название

A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Preliminary Efficacy of KNT-0916 in Subjects With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

Обзор

This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. This study is divided into 2 parts, dose escalation part(part A), dose expansion part(partB).

Подробное описание

This study is divided into 2 parts, part a isNdesigned to explore the maximum toxicity dose (MTD) of KNT-0916 with an accelerated titration plus traditional "3+3" design; part b is designed to explore the elementary anti-neoplastic activity of KNT-0916 with recommended dose in patients with confirmed FGFR2 alterations through central laboratory testing.

Вмешательства

• Препарат KNT-0916
  • KNT-0916 is an oral inhibitor of FGFR2.

Первичные конечные точки

• Dose-limiting Toxicity (DLT) [Срок оценки: 4 weeks]
• Maximum tolerated dose (MTD) or Maximum administered dose (MAD) [Срок оценки: 12 months]
• Incidence, relatedness, seriousness and severity of adverse events (AEs) per the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) Version 5.0. [Срок оценки: 33 months]
• Recommended phase 2 dose (RP2D) [Срок оценки: 33 months]

Вторичные конечные точки (10)

• Objective response rate (ORR) assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Срок оценки: 33 months]
• Duration of response (DoR) assessed as per RECIST 1.1 [Срок оценки: 33 months]
• Disease control rate (DCR) assessed as per RECIST 1.1 [Срок оценки: 33 months]
• Progression-free survival (PFS) assessed as per RECIST 1.1 [Срок оценки: 33 months]
• Overall survival (OS) assessed as per RECIST 1.1 [Срок оценки: 33 months]
• Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) [Срок оценки: 33 months]
• Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC) [Срок оценки: 33 months]
• Pharmacokinetic parameters including half-life (t1/2) [Срок оценки: 33 months]
• Pharmacokinetic parameters including time to maximum concentration (Tmax) [Срок оценки: 33 months]
• Pharmacokinetic parameters including Apparent clearance (CL/F) [Срок оценки: 33 months]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed unresectable or metastatic solid tumor
• Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor
• Patient must have measurable disease per RECIST v1.1
• Patient has ECOG performance status of 0-1
• Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
• An expected survival of ≥ 12 weeks.
• Adequate organ function, as measured by laboratory values

Критерии исключения

• Prior treatment with any FGFR2 target therapy.
• Central nervous system metastasis with associated symptom and signs.
• Clinically significant, uncontrolled cardiovascular disease.
• History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06800196 · EO002-CP002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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