NCT06838338

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

A Phase Ib, Open Lable, Clinical Trial of JAB-21822 Combined With Second Line Chemotherapy and Bevacizumab for Metastatic Colorectal Cancer With KRAS G12C Mutation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jian Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is aimed for patients with histologically confirmed advanced metastatic colorectal cancer with KRAS G12C mutation, patients enrolled will treated with JAB-21822 combined with standard second-line chemotherapy and bevacizumab until disease progression or intolerable toxicity or patient-initiated withdrawal from the study. Enrolled patients will undergo imaging assessments at baseline and every 6 weeks during the treatment period, the anti-tumor efficacy will be evaluated by the investigator according to RECIST v1.1. Safety assessment included vital signs, haematology, blood biochemistry and urinalysis and will be monitored regularly during the study period during treatment. Any discomfort experienced by the patients after administration of the drug will also be recorded.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	JAB-21822	Tablet, oral, 800 mg/QD, until PD or intolerable toxicity
DRUG	standard second-line chemotherapy	The second line standard chemotherapy regimen recommended by clinical practice
DRUG	Bevacizumab	5mg/kg every two weeks (according to the assessment by investigator)

Timeline

• Start date: 2025-03-20
• Primary completion: 2026-03-01
• Completion: 2026-08-01
• First posted: 2025-02-20
• Last updated: 2026-01-08

Locations

4 sites across 1 country: China