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

Sponsor
Jian Li
Study ID
NCT06838338
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 20, 2025
Start date
Mar 20, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JAB-21822 and second-line standard chemotherapy with bevacizumab
    Patients receive JAB-21822 combined with chemotherapy with bevacizumab as the second-line treatment until disease progression or intolerable toxicity

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Time Frame: up to 1year ]

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