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

NCT06838338 | Active Not Recruiting Phase 1

• 1 other identifier: JAB-21822-CRC003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The percentage of patients with total number of Complete Response (CR) + total number of Partial Response (PR) per RECIST v1.1

  Time Frame: up to 1year

Secondary Outcomes (5)

• Overall Survival (OS)

  Time Frame: up to 1 year

• Progression-free Survival (PFS)

  Time Frame: up to 1 year

• Disease Control Rate (DCR)

  Time Frame: up to 1 year

• Duration of Response (DOR)

  Time Frame: up to 1 year

• Rate of treatment-related adverse events

  Time Frame: up to 1 year

Study Arms (1)

JAB-21822 and second-line standard chemotherapy with bevacizumab

EXPERIMENTAL

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

Drug: JAB-21822; Drug: standard second-line chemotherapy; Drug: Bevacizumab

Interventions

JAB-21822 DRUG

Tablet, oral, 800 mg/QD, until PD or intolerable toxicity

JAB-21822 and second-line standard chemotherapy with bevacizumab

standard second-line chemotherapy DRUG

The second line standard chemotherapy regimen recommended by clinical practice

Also known as: FOLFIRI, FOLFOX

JAB-21822 and second-line standard chemotherapy with bevacizumab

Bevacizumab DRUG

5mg/kg every two weeks (according to the assessment by investigator)

JAB-21822 and second-line standard chemotherapy with bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian Li: lead

Study Sites (4)

Beijing Cancer Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Peking University Cancer Hospital (Inner Mongolia Campus)/Afffliated Cancer Hospital of Inner Mongolia Medical University

Hohhot, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jacobio Pharmaceuticals

  Jacobio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: February 20, 2025
• Study Start: March 20, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (4)