Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| JAB-21822 | Drug | — | UNRESOLVED |
| standard second-line chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JAB-21822 and second-line standard chemotherapy with bevacizumab
- description
- Patients receive JAB-21822 combined with chemotherapy with bevacizumab as the second-line treatment until disease progression or intolerable toxicity
- interventionNames
- Drug: JAB-21822
- Drug: standard second-line chemotherapy
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Time Frame: up to 1year
- description
- The percentage of patients with total number of Complete Response (CR) + total number of Partial Response (PR) per RECIST v1.1
Secondary outcomes (5)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available