A Study of TXN10128 in Subjects With Solid Tumors

Официальное название

A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 as Monotherapy and Combination Therapy With Irinotecan or Paclitaxel in Locally Advanced or Metastatic Solid Tumors

Обзор

This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors. This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part.

Подробное описание

This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part. The study includes dose-escalation and dose-expansion parts across three cohorts: TXN10128 monotherapy (Cohorts A) TXN10128 + Irinotecan (Cohorts B) and TXN10128+ Paclitaxel (Cohorts C).

Вмешательства

• Препарат TXN10128
  TXN10128: Oral administration once daily everyday
• Препарат Irinotecan
  Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle
• Препарат Paclitaxel
  IV administration at 80 mg/m2 three times (Day 1, Day 8, and Day 15) at intervals of 1 week in one cycle (IV administration at 90 mg/m2 for patients with breast cancer)

Первичные конечные точки

• DLT [Срок оценки: Day 1 up to Day 21 for Cohort A(TXN10128 mono cohort) and Day 1 up to Day 28 for Cohort B,C(TXN10128 combination with Irinotecan or paclitaxel cohort) in dose escalation period]
• Adverse events (AE) [Срок оценки: Up to 30 days from end of treatment]

Вторичные конечные точки (11)

• Cmax [Срок оценки: Up to 21 days from Day 1 dose]
• AUC inf [Срок оценки: Up to 21 days from Day 1 dose]
• AUC last [Срок оценки: Up to 21 days from Day 1 dose]
• Tmax [Срок оценки: Up to 21 days from Day 1 dose]
• T1/2 [Срок оценки: Up to 21 days from Day 1 dose]
• Vss [Срок оценки: Up to 21 days from Day 1 dose]
• Best overall response (BOR) [Срок оценки: Up to 30 days from end of treatment]
• Progression free survival (PFS) [Срок оценки: Up to 30 days from end of treatment]
• Disease control rate (DCR) [Срок оценки: Up to 30 days from end of treatment]
• Duration of Response (DOR) [Срок оценки: Up to 30 days from end of treatment]
• Overall response rate (ORR) [Срок оценки: Up to 30 days from end of treatment]

Критерии участия

Критерии включения

• Male or female subjects ≥19 years of age at the time of informed consent.
• Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, or standard therapy does not exist or is not considered appropriate.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 12 weeks.

Критерии исключения

• Has leptomeningeal disease.
• Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.
• Prior organ transplantation.
• Known positive human immunodeficiency virus (HIV) infection.

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

South Korea · 6 центров

• Seoul National University Bundang Hospital — Seongnam-si
• Chungbuk National University Hospital — Cheonju
• Seoul National Univ. Hospital — Seoul
• Asan Medical Center — Seoul
• Gachon University Gil Medical Center — Incheon
• SAMSUNG Medical Center — Seoul

Идентификаторы

NCT: NCT05978492 · TXN10128-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗