A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors

Официальное название

A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy

Обзор

The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD/MAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in patients with VHL Syndrome Associated Tumors.

Подробное описание

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.

Вмешательства

• Препарат Oral HS-10516
  Oral HIF-2α inhibitor

Первичные конечные точки

• Phase Ia: MTD/MAD of HS-10516 [Срок оценки: Approximately 2 months]
• Phase Ib: Objective Response Rate (ORR) by Independent Review Committee (IRC) [Срок оценки: Approximately 1 year]

Вторичные конечные точки (9)

• The Number of Participants with Adverse Events [Срок оценки: Approximately 2 years]
• Observed maximum plasma concentration (Cmax) of HS-10516 [Срок оценки: Approximately 2 months]
• Time to reach maximum plasma concentration (Tmax) of HS-10516 [Срок оценки: Approximately 2 months]
• Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-10516 [Срок оценки: Approximately 1 year]
• ORR by investigators/IRC per system [Срок оценки: Approximately 1 year]
• Disease Control Rate (DCR) by investigators/IRC per system [Срок оценки: Approximately 1 year]
• Duration of Response (DoR) by investigators/IRC per system [Срок оценки: Approximately 1 year]
• Progression Free Survival (PFS) by investigators/IRC per system [Срок оценки: Approximately 2 years]
• Overall Survival (OS) [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Male or female from 18 to 80 year-old
• Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
• Has an Eastern Cooperative Oncology Group performance status of 0-1
• Has a life expectancy of ≥ 12 weeks
• Should use adequate contraceptive measures throughout the study
• Females subject must not be pregnant at screening
• Has the ability to understand and willingness to sign a written informed consent before the performance of the study.

Критерии исключения

• Recieved or being received treatment as follows:

• Hypoxia-induced factor inhibitors
• Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
• Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
• Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
• Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.
• Major surgery within 4 weeks prior to the first dose of study treatment.
• Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
• Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
• Has another malignancy or a history of another non-VHL syndrome associated malignancy
• Has inadequate bone marrow reserve or organ dysfunction
• Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
• Has severe infections within 4 weeks prior to the first dose of study treatment
• Has digestive system diseases may influencing ADME of study drug
• Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin
• Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision

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 · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06553339 · HS-10516-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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