Colorectal CancerPhase 1NCT06838338
JAB-21822 Combined With Chemotherapy and Bevacizumab in Second-line KRAS G12C CRC
A Phase 1 study testing JAB-21822, standard second-line chemotherapy and Bevacizumab in people with Colorectal Cancer, run by Jian Li at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- JAB-21822, standard second-line chemotherapy and Bevacizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 20 Mar 2025to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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- Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Cancer Hospital
Beijing
Peking University First Hospital
Beijing
Peking University Cancer Hospital (Inner Mongolia Campus)/Afffliated Cancer Hospital of Inner Mongolia Medical University
Hohhot
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: 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
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.
Read the detailed description
The study is aimed for patients with histologically confirmed advanced metastatic colorectal cancer with KRAS G12C mutation, patients enrolled will treated with JAB-21822 combined with standard second-line chemotherapy and bevacizumab until disease progression or intolerable toxicity or patient-initiated withdrawal from the study. Enrolled patients will undergo imaging assessments at baseline and every 6 weeks during the treatment period, the anti-tumor efficacy will be evaluated by the investigator according to RECIST v1.1. Safety assessment included vital signs, haematology, blood biochemistry and urinalysis and will be monitored regularly during the study period during treatment. Any discomfort experienced by the patients after administration of the drug will also be recorded.
- Conditions
- Colorectal Cancer
- Being tested
- JAB-21822, standard second-line chemotherapy, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-21822Drug
Tablet, oral, 800 mg/QD, until PD or intolerable toxicity
standard second-line chemotherapyDrug
Also called FOLFIRI, FOLFOX
The second line standard chemotherapy regimen recommended by clinical practice
BevacizumabDrug
5mg/kg every two weeks (according to the assessment by investigator)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: JAB-21822; Drug: standard second-line chemotherapy; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: up to 1year
Secondary outcomes (5)
Overall Survival (OS)
Defined as the time from date of study treatment to death due to any cause.
Measured: Time Frame: up to 1 year
Progression-free Survival (PFS)
Defined as the time from date of study treatment to disease progression radiological/clinical or death due to any cause, whichever occurs first.
Measured: Time Frame: up to 1 year
Disease Control Rate (DCR)
Defined as the percentage of patients whose best response are not Progressive Disease (PD) according to RECIST v1.1.
Measured: Time Frame: up to 1 year
Duration of Response (DOR)
Defined as the time between the first assessment of the tumor as a CR or PR and the first assessment as disease progression (PD) or death from any cause.
Measured: Time Frame: up to 1 year
Rate of treatment-related adverse events
Number of patients with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Time Frame: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Li, Peking University Cancer Hospital & Institute
- Investigators
- Jacobio Pharmaceuticals, Study director, Jacobio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838338
- Sponsor's protocol ID
- JAB-21822-CRC003
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06838338
- Acronym / sponsor ID
- JAB-21822-CRC003
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jian LiUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is aimed for patients with histologically confirmed advanced metastatic colorectal cancer with KRAS G12C mutation, patients enrolled will treated with JAB-21822 combined with standard second-line chemotherapy and bevacizumab until disease progression or intolerable toxicity or patient-initiated withdrawal from the study. Enrolled patients will undergo imaging assessments at baseline and every 6 weeks during the treatment period, the anti-tumor efficacy will be evaluated by the investigator according to RECIST v1.1. Safety assessment included vital signs, haematology, blood biochemistry and urinalysis and will be monitored regularly during the study period during treatment. Any discomfort experienced by the patients after administration of the drug will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAB-21822 and second-line standard chemotherapy with bevacizumab | Experimental | Drug: JAB-21822, Drug: standard second-line chemotherapy, Drug: BevacizumabPatients receive JAB-21822 combined with chemotherapy with bevacizumab as the second-line treatment until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-21822Tablet, oral, 800 mg/QD, until PD or intolerable toxicity | Drug | JAB-21822 and second-line standard chemotherapy with bevacizumab |
| standard second-line chemotherapyAlso: FOLFIRI, FOLFOXThe second line standard chemotherapy regimen recommended by clinical practice | Drug | JAB-21822 and second-line standard chemotherapy with bevacizumab |
| Bevacizumab5mg/kg every two weeks (according to the assessment by investigator) | Drug | JAB-21822 and second-line standard chemotherapy with bevacizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Time Frame: up to 1year
The percentage of patients with total number of Complete Response (CR) + total number of Partial Response (PR) per RECIST v1.1
5 secondary outcomes
Overall Survival (OS)
Time frame: Time Frame: up to 1 year
Progression-free Survival (PFS)
Time frame: Time Frame: up to 1 year
Disease Control Rate (DCR)
Time frame: Time Frame: up to 1 year
Duration of Response (DOR)
Time frame: Time Frame: up to 1 year
Rate of treatment-related adverse events
Time frame: Time Frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobio Pharmaceuticals study director
Jacobio Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JAB-21822, standard second-line chemotherapy and Bevacizumab in people with Colorectal Cancer, run by Jian Li at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Time Frame: up to 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.