KRAS P.G12CPhase 2NCT06008288
A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.
A Phase 2 study testing JAB-21822 in people with KRAS P.G12C and Pancreatic Cancer, run by Allist Pharmaceuticals, Inc. at 31 sites in China.
Trial summary
Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS P.G12C, Pancreatic Cancer, Solid Tumor
- What is being tested?
- JAB-21822
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 31 sitesChina
- Study dates
- 27 Oct 2023to 31 Dec 2027
- Phase
- Phase 2
- 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
- Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC).
- Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.
Who cannot join
- Previously received a KRAS G12C inhibitor.
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
- Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites, 31 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital of Sun, Yat-sen University
Guangzhou, Guangdong
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
- Recruiting
Tianjin Medical University Cancer Institute＆Hospital
Tianjin, Tianjin Municipality
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.
Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.
Read the detailed description
This study is a single-arm, multicenter, open-label, basket-design, pivotal phase II trial targeting adult patients with locally advanced or metastatic solid tumors harboring the KRAS p.G12C mutation. The included populations are:
- Patients with advanced pancreatic cancer who have progressed or are intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatments.
- Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapies or are intolerant and lack satisfactory alternative treatment options.
The study aims to evaluate the efficacy and safety of Glecirasib in these patient populations.
- Conditions
- KRAS P.G12C, Pancreatic Cancer, Solid Tumor
- Being tested
- JAB-21822
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-21822Drug
Also called Glecirasib
800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
| Study group | Role | What they receive |
|---|---|---|
| JAB-21822 | Experimental | Monotherapy Receives: Drug: JAB-21822 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
Measured: Approximately 1.5 years
Secondary outcomes (7)
Duration of response (DOR)
DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Measured: Approximately 1.5 years
Time to response (TTR) by IRC according to RECIST 1.1
TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
Measured: Approximately 1.5 years
Progression-free survival (PFS) by IRC according to RECIST 1.1
PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Measured: Approximately 1.5 years
Disease control rate (DCR) by IRC according to RECIST 1.1
DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
Measured: Approximately 1.5 years
CA19-9 response rate (Applicable only to pancreatic cancer)
CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).
Measured: Approximately 1.5 years
Overall survival (OS)
OS is defined as time from date of the first dose to date of death due to any cause.
Measured: Approximately 2.0 years
Number of participants with adverse events
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Measured: Approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start27 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS P.G12CStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanghai Allist Pharmaceuticals, Study director, Shanghai Allist Pharmaceuticals Co.,Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008288
- Sponsor's protocol ID
- JAB-21822-2001
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2023
- Last updated
- 13 Mar 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.
- ClinicalTrials.gov ID
- NCT06008288
- Acronym / sponsor ID
- JAB-21822-2001
- Conditions
- KRAS P.G12C, Pancreatic Cancer, Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Aug 2023 (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.
Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.
Detailed description
This study is a single-arm, multicenter, open-label, basket-design, pivotal phase II trial targeting adult patients with locally advanced or metastatic solid tumors harboring the KRAS p.G12C mutation. The included populations are:
- Patients with advanced pancreatic cancer who have progressed or are intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatments.
- Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapies or are intolerant and lack satisfactory alternative treatment options.
The study aims to evaluate the efficacy and safety of Glecirasib in these patient populations.
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 | Experimental | Drug: JAB-21822Monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC).
- Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.
Key exclusion criteria (5 listed)
- Previously received a KRAS G12C inhibitor.
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
- Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.
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-21822Also: Glecirasib800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons | Drug | JAB-21822 |
Primary outcome
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
Time frame: Approximately 1.5 years
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
7 secondary outcomes
Duration of response (DOR)
Time frame: Approximately 1.5 years
Time to response (TTR) by IRC according to RECIST 1.1
Time frame: Approximately 1.5 years
Progression-free survival (PFS) by IRC according to RECIST 1.1
Time frame: Approximately 1.5 years
Disease control rate (DCR) by IRC according to RECIST 1.1
Time frame: Approximately 1.5 years
CA19-9 response rate (Applicable only to pancreatic cancer)
Time frame: Approximately 1.5 years
Overall survival (OS)
Time frame: Approximately 2.0 years
Number of participants with adverse events
Time frame: Approximately 1.5 years
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 13 Mar 2026.
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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.
Shanghai Allist Pharmaceuticals study director
Shanghai Allist Pharmaceuticals Co.,Ltd.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JAB-21822 in people with KRAS P.G12C and Pancreatic Cancer, run by Allist Pharmaceuticals, Inc. at 31 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Shanghai Allist Pharmaceuticals Co., Ltd (86-21-80423288, zhenhua.gong@allist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1. (time frame: Approximately 1.5 years). 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 13 Mar 2026.