NCT06838338Active, not recruitingPhase 1
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 · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Sept 2024
- Start date
- 20 Mar 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Jian Li
- Diseases
- Colorectal cancer
- NCT number
- NCT06838338
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 20 Mar 2025 to the primary completion date, Mar 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients have received KRAS G12C inhibitors.
- Patients have received a first-line treatment, which include fluoropyrimidine, oxaliplatin and irinotecan.
- 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.
- Prior history of interstitial lung disease or non-infectious pneumonia; history of active tuberculosis.
Other illness
- Patients with active ulcers and gastrointestinal bleeding.
- Patients with other malignancies within five years.
Lab values
- Patients with clinically diagnosed autoimmune disease; HIV, HCV positive; HBV-DNA beyond the normal range of the laboratory; Acute CMV infection.
Other
- Patients who are pregnant or breastfeeding.
- Life expectancy of less than 3 months.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Patients with active central nervous system metastases requiring treatment.
- Assessed by the investigator, patients who are unable or unwilling to comply with the requirements of the study protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Cancer Hospital (Inner Mongolia Campus)/Afffliated Cancer Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.