Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Официальное название

A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JYP0015 in Advanced Solid Tumors With RAS Mutation

Обзор

Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.

Подробное описание

This is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of JYP0015 in adult patients with advanced solid tumors harboring specific RAS mutations.

The study consists of two parts:

* Phase 1 (dose escalation) - Evaluates the safety, tolerability, and pharmacokinetic profile of JYP0015 monotherapy, preliminarily assesses efficacy, and determines the recommended dose (RD) for further evaluation. * Phase 2 (indication expansion) - Explores the therapeutic potential of JYP0015 monotherapy at the RD across four predefined cohorts:

1. Pancreatic ductal adenocarcinoma (PDAC) 2. Non-small cell lung cancer (NSCLC) 3. Colorectal cancer (CRC) 4. Other advanced solid tumors Phase 2 will assess both efficacy and safety within these cohorts.

JYP0015 is a potent, orally bioavailable pan-RAS inhibitor that selectively targets the active (ON) form of wild-type and mutant RAS across all three isoforms-HRAS, NRAS, and KRAS.

Вмешательства

• Препарат JYP0015
  JYP0015 is an orally bioavailable pan-RAS inhibitor designed to target the active (ON) form of wild-type and mutant RAS across KRAS, NRAS, and HRAS isoforms. The drug will be administered orally, with dosing determined by the study protocol in the dose-escalation and indication-expansion phases.

Первичные конечные точки

• Number of Participants with Dose-Limiting Toxicity (DLT) [Срок оценки: 21 days]
• Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs [Срок оценки: Up to 3 years]
• Overall Response Rate (ORR) [Срок оценки: Up to 3 years]

Вторичные конечные точки (4)

• Maximum Observed Blood Concentration (Cmax) of JYP0015 [Срок оценки: Up to 16 weeks]
• Time to Reach Maximum Blood Concentration (Tmax) of JYP0015 [Срок оценки: Up to 16 weeks]
• Duration of Response (DOR) [Срок оценки: Up to 3 years]
• Time to Response (TTR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
• Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
• Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
• Adequate organ function

Критерии исключения

• Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
• Gastrointestinal (GI) disorders that may interfere with drug administration/absorption, including but not limited to: Dysphagia or inability to swallow tablets， Malabsorption syndrome，Refractory nausea, vomiting, or diarrhea，Chronic GI diseases (e.g., Crohn's disease, ulcerative colitis)
• Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) <50%.
• Any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: Alcohol or substance abuse，Concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment)， Familial or social circumstances that may affect patient safety, compliance, or study data collection.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06895031 · JYP0015M101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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