Combining JAB-21822 with chemotherapy for advanced colorectal cancer

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

This study is testing if a new drug called JAB-21822 can work better when combined with regular chemotherapy for people with advanced colorectal cancer who haven't responded to previous treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: chemotherapy, bevacizumab
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06838338 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of the KRAS G12C inhibitor JAB-21822 in combination with standard second-line chemotherapy in patients with advanced colorectal cancer who have previously failed standard treatment. Participants will receive treatment until disease progression or intolerable toxicity occurs, with regular imaging assessments to evaluate anti-tumor efficacy. Safety will be monitored through vital signs, blood tests, and patient-reported outcomes during the treatment period.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed unresectable metastatic colorectal cancer and a KRAS G12C mutation who have progressed on first-line therapy.

Not a fit: Patients who have previously received KRAS G12C inhibitors or first-line treatments that include fluoropyrimidine, oxaliplatin, or irinotecan may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for Chinese patients with advanced colorectal cancer harboring the KRAS G12C mutation.

How similar studies have performed: Other studies have shown promising results with KRAS G12C inhibitors in advanced colorectal cancer, indicating potential for success in this approach.

Eligibility criteria

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* Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease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.

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jacobio Pharmaceuticals

Conditions Colorectal Cancer