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Advanced Colorectal CancerPhase 1/2NCT05194995

JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

A Phase 1/2 study testing JAB-21822 and Cetuximab in people with Advanced Colorectal Cancer and Small Intestinal Cancer, run by Allist Pharmaceuticals, Inc. at 17 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JAB-21822 and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
17 sitesChina
Study dates
17 Feb 2022to Dec 2026
Phase
Phase 1/2
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

  • Participants must be able to provide an archived tumor sample
  • Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation
  • Must have received at least 1 prior standard therapy
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Must have adequate organ function
  • Must be able to swallow and retain orally administered medication

Who cannot join

  • Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 14 days
  • Active HIV, HBV or HCV
  • Any severe and/or uncontrolled medical conditions
  • LVEF<50% assessed by ECHO
  • QT interval >470 msec

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Research site31

    Beijing, Beijing Municipality, 100021

  • Research site01

    Beijing, Beijing Municipality, 100101

  • Research site02

    Beijing, Beijing Municipality, 100101

  • Research site12

    Beijing, Beijing Municipality, 100101

  • Research site11

    Changsha, Hunan, 410000

  • Research site29

    Changsha, Hunan, 410000

  • Research site19

    Hangzhou, Zhejiang, 310005

  • Research site06

    Harbin, Heilongjiang, 150000

  • Research site16

    Linyi, Shandong, 276002

  • Research site08

    Nanchang, Jiangxi, 330000

  • Research site09

    Nanjing, Jiangsu, 210000

  • Research site13

    Nanning, Guangxi, 530021

  • Research site28

    Shanghai, Shanghai Municipality, 200032

  • Research site18

    Wuhan, Hubei, 430079

  • Research site23

    Xi’an, Shanxi, 710000

  • Research site05

    Zhengzhou, Henan, 450000

  • Research site07

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation

This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Read the detailed description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Being tested
JAB-21822, Cetuximab
Medical subject headings
Appendiceal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JAB-21822Drug

    JAB-21822 administered orally as a tablet.

  • CetuximabDrug

    Cetuximab administered as an intravenous (IV) infusion.

Study groups in NCT05194995
Study groupRoleWhat they receive
Phase 1b Dose EscalationExperimentalDose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.
Receives: Drug: JAB-21822; Drug: Cetuximab
Phase 2 Dose Expansion, Cohort 1ExperimentalEnrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
Receives: Drug: JAB-21822; Drug: Cetuximab
Phase 2 Dose Expansion, Cohort 2ExperimentalEnrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.
Receives: Drug: JAB-21822; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs)

    A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  2. Dose Expansion phase: Overall response rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.

    Measured: Up to 4 years - from baseline to RECIST confirmed Progressive Disease

Secondary outcomes (7)

  1. Dose Escalation and Dose Expansion phase: Number of participants with adverse events

    Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria.

    Measured: Up to 4 years

  2. Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)

    Cmax of JAB-21822 will be measured by using plasma PK samples.

    Measured: Up to 4 years

  3. Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)

    AUC of JAB-21822 will be measured by using plasma PK samples.

    Measured: Up to 4 years

  4. Dose Expansion phase: Duration of response ( DOR )

    DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to 4 years

  5. Dose Escalation phase: Overall response rate (ORR)

    The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.

    Measured: Up to 4 years

  6. Dose Expansion phase: Disease Control Rate ( DCR )

    DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1.

    Measured: Up to 4 years

  7. Dose Expansion phase: Progression-free survival (PFS)

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start17 Feb 2022
  3. Primary completion30 Apr 2025
  4. Study completionDec 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194995
Sponsor's protocol ID
JAB-21822-1007
Status last verified
Mar 2026
First submitted
27 Dec 2021
Last updated
16 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jiang L, Luo Y, Liang H, Feng X, Huang Y, Li Y, Wang Z, Xu T, Zou H, Li Z, Shen L, Chen Y, Wang W, Li J. The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. Hum Cell. 2026 Jul 1;39(7):95. doi: 10.1007/s13577-026-01405-0.

    PubMed 42384131

  • Li J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):110-123. doi: 10.1016/S2468-1253(25)00267-5. Epub 2025 Dec 1.

    PubMed 41344351

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-21822 and Cetuximab in people with Advanced Colorectal Cancer and Small Intestinal Cancer, run by Allist Pharmaceuticals, Inc. at 17 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 6 inclusion and 6 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 16 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 17 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 combined 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.

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?

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?

Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194995, which also lists 2 linked publications.

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 16 Mar 2026.

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