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Clinical Trials in China / NCT06838338
Active, not recruiting Phase 1

JAB-21822 Combined With Chemotherapy and Bevacizumab in Second-line KRAS G12C CRC

NCT06838338 · tracked via the Priya Life Science China tracker
Sponsor
Jian Li
Phase
Phase 1
Started
2025-03-20
Last updated
2026-01-08

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

JAB-21822standard second-line chemotherapyBevacizumab

JAB-21822: Tablet, oral, 800 mg/QD, until PD or intolerable toxicity

standard second-line chemotherapy: The second line standard chemotherapy regimen recommended by clinical practice

Bevacizumab: 5mg/kg every two weeks (according to the assessment by investigator)

Study summary

KRAS is a common genetic mutation in tumors, and CRC is one of the tumors with a high KRAS mutation rate. The anti-tumor activity of KRAS G12C inhibitors combined with anti-EGFR anti-bodies have been proven in patients with advanced colorectal cancer, and one of them was approved for patients who have previously received standard treatment. However, Chinese patients still do not have access to these drugs. This study is to determine the efficacy and safety of KRAS G12C inhibitor JAB-21822 in combination with the second-line standard chemotherapy and bevacizumab in advanced colorectal cancer failed to standard therapy in Chinese population.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically (or cytologically) confirmed, unresectable metastatic colorectal cancer. * KRAS G12C mutation. * At least one measurable disease per RECIST v1.1; assessed within 28 days before first dose. * Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease progression must within three months; first-line chemotherapy regimens do not limit the use of antiangiogenic agents. * Adequate bone marrow, liver and renal function. * ECOG performance status 0-1. * Informed consent has been signed. Exclusion Criteria: * Patients have received KRAS G12C inhibitors. * Patients have received a first-line treatment, which include fluoropyrimidine, oxaliplatin and irinotecan. * Patients who are pregnant or breastfeeding. * Life expectancy of less than 3 months. * Patients who had major surgery or significant trauma within 4 weeks prior to the first blood sample collection during the screening period, or expected to require major surgery during the study period. * Patients with active ulcers and gastrointestinal bleeding. * Prior history of interstitial lung disease or non-infectious pneumonia; history of active tuberculosis. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. * Patients with clinically diagnosed autoimmune disease; HIV, HCV positive; HBV-DNA beyond the normal range of the laboratory; Acute CMV infection. * Patients with active central nervous system metastases requiring treatment. * Patients with other malignancies within five years. * Assessed by the investigator, patients who are unable or unwilling to comply with the requirements of the study protocol.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China
Peking University First Hospital Beijing China
Peking University Cancer Hospital (Inner Mongolia Campus)/Afffliated Cancer Hospital of Inner Mongolia Medical University Hohhot China
Fudan University Shanghai Cancer Center Shanghai China

On this site

📄 Avastin (bevacizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06838338 on ClinicalTrials.gov ↗ ← All trials in China