A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

Официальное название

A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

Обзор

Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation.

Подробное описание

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..

Вмешательства

• Препарат JAB 21822
  Administered orally

Первичные конечные точки

• Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
• Dose Escalation phase: Number of participants with adverse events [Срок оценки: Up to 3 years]
• Dose Expansion phase: Objective response rate (ORR) [Срок оценки: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.]

Вторичные конечные точки (10)

• Dose Escalation phase: Objective response rate (ORR) [Срок оценки: Up to 3 years - from baseline to RECIST confirmed Progressive Disease]
• Dose Escalation and Dose Expansion phase: Progression-free survival (PFS) [Срок оценки: Up to 3 years]
• Dose Escalation and Dose Expansion phase: Duration of response (DOR) [Срок оценки: Up to 3 years]
• Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR) [Срок оценки: Up to 3 years]
• Dose Escalation and Dose Expansion phase: Overall Survival (OS) [Срок оценки: Up to 3 years]
• Dose Escalation and Dose Expansion phase: Time to response (TTR) [Срок оценки: Up to 3 years]
• Dose Expansion phase: Number of participants with adverse events [Срок оценки: Up to 3 years]
• Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax) [Срок оценки: Up to 3 Years]
• Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax) [Срок оценки: Up to 3 Years]
• Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC) [Срок оценки: Up to 3 Years]

Критерии участия

Критерии включения

• Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
• STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
• Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
• ECOG 0-1

Критерии исключения

• Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
• Any severe and/or uncontrolled medical conditions
• Active infection requiring systemic treatment within 7 days
• Therapeutic radiation therapy within 3 weeks of study day 1

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 · 21 центр

• Research site08 — Пекин
• Research site09 — Пекин
• Research site021 — Пекин
• Research site02 — Пекин
• Research site01 — Пекин
• Research site013 — Пекин
• Research site010 — Чунцин
• Research site05 — Xiamen
• … и ещё 13 центров

Идентификаторы

NCT: NCT05276726 · JAB-21822-1003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗