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Recruiting NCT06008288

A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.

Phase II Interventional KRAS P.G12C Pancreatic Cancer Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB-21822.
Who it may be relevant to
Registry conditions: KRAS P.G12C, Pancreatic Cancer, Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.

Overview

Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.

Detailed description

This study is a single-arm, multicenter, open-label, basket-design, pivotal phase II trial targeting adult patients with locally advanced or metastatic solid tumors harboring the KRAS p.G12C mutation. The included populations are:

* Patients with advanced pancreatic cancer who have progressed or are intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatments. * Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapies or are intolerant and lack satisfactory alternative treatment options.

The study aims to evaluate the efficacy and safety of Glecirasib in these patient populations.

Interventions

  • Drug JAB-21822
    800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

Primary outcome measures

  • Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1. [Time frame: Approximately 1.5 years]
Secondary outcome measures (7)
  • Duration of response (DOR) [Time frame: Approximately 1.5 years]
  • Time to response (TTR) by IRC according to RECIST 1.1 [Time frame: Approximately 1.5 years]
  • Progression-free survival (PFS) by IRC according to RECIST 1.1 [Time frame: Approximately 1.5 years]
  • Disease control rate (DCR) by IRC according to RECIST 1.1 [Time frame: Approximately 1.5 years]
  • CA19-9 response rate (Applicable only to pancreatic cancer) [Time frame: Approximately 1.5 years]
  • Overall survival (OS) [Time frame: Approximately 2.0 years]
  • Number of participants with adverse events [Time frame: Approximately 1.5 years]

Eligibility criteria

Inclusion criteria

  • Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods.
  • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC).
  • Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.

Exclusion criteria

  • Previously received a KRAS G12C inhibitor.
  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
  • Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 31 centers
  • Anhui Provincial Cancer Hospital — Hefei
  • Beijing Cancer Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Beijing Tsinghua Changgung Hospital — Beijing
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Fujian Cancer Hospital — Fuzhou
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
  • Sun Yat-Sen University Cancer Center — Guangzhou
  • … and 23 more centers

Identifiers

NCT: NCT06008288 · JAB-21822-2001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗