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Advanced Solid TumorPhase 1/2NCT05002270

JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

A Phase 1/2 study testing JAB-21822 (KRAS G12C inhibitor) and Cetuximab (EGFR inhibitor) in people with Advanced Solid Tumor and NSCLC, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, NSCLC, CRC
What is being tested?
JAB-21822 (KRAS G12C inhibitor) and Cetuximab (EGFR inhibitor)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
4 sitesUnited States
Study dates
3 Sep 2021to 12 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 solid tumors with KRAS 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 or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 7 days
  • Active HBV or HCV
  • Any severe and/or uncontrolled medical conditions
  • LVEF ≤50% assessed by ECHO or QTcF
  • QT interval >470 msec
  • Experiencing unresolved CTCAE 5.0 Grade >1 toxicities

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Mayo Clinc

    Jacksonville, Florida, 32224

  • Mayo Clinc

    Phoenix, Arizona, 85054

  • University of Utah

    Salt Lake City, Utah, 84112

  • Mayo Clinc

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Read the detailed description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Being tested
JAB-21822 (KRAS G12C inhibitor), Cetuximab (EGFR inhibitor)
Keywords
KRAS G12C Mutant Advanced Solid Tumor; NSCLC; CRC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • JAB-21822 (KRAS G12C inhibitor)Drug

    Administered orally

  • JAB-21822 (KRAS G12C inhibitor)Drug

    Administered orally

  • JAB-21822 (KRAS G12C inhibitor)Drug

    Administered orally

  • Cetuximab (EGFR inhibitor)Drug

    Administered IV

Study groups in NCT05002270
Study groupRoleWhat they receive
Arm A0, JAB-21822 monotherapy, Phase 1, Dose EscalationExperimentalDose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D
Receives: Drug: JAB-21822 (KRAS G12C inhibitor)
Arm A1, JAB-21822 monotherapy, Phare 2, Dose ExpansionExperimentalJAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.
Receives: Drug: JAB-21822 (KRAS G12C inhibitor)
Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose ExpansionExperimentalJAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity.
Receives: Drug: JAB-21822 (KRAS G12C inhibitor); Drug: Cetuximab (EGFR inhibitor)

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)

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

  2. 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

  3. 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

  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

Secondary outcomes (6)

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

    Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples

    Measured: Up to 4 years

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

    AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples

    Measured: Up to 4 years

  3. 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 - from baseline to RECIST confirmed Progressive Disease

  4. Dose Escalation 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 and 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

  6. Dose Escalation and 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 posted12 Aug 2021
  2. Study start3 Sep 2021
  3. Primary completion12 Feb 2025
  4. Study completion12 Feb 2025

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002270
Sponsor's protocol ID
JAB-21822-1001
Status last verified
Jan 2026
First submitted
26 Jul 2021
Last updated
13 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Li J, Deng T, Gu Y, Calles Blanco A, Li Z, Bai C, Wu L, Huang J, Li X, Yao Y, Song Z, Li Y, Liu L, Xing L, Wu W, Martinez-Perez J, Hubert A, Zugazagoitia J, Zhang J, Wang Y, Zhao Y, Wen G, Xia G, Zhong D, Chen X, Jiang K, Wang-Gillam A, Ding Y, Liu S, Rao Z, Liu X, Shen L. Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials. Cancer Commun (Lond). 2025 Nov;45(11):1500-1512. doi: 10.1002/cac2.70056. Epub 2025 Oct 2.

    PubMed 41037823

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-21822 (KRAS G12C inhibitor) and Cetuximab (EGFR inhibitor) in people with Advanced Solid Tumor and NSCLC, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.

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 7 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: finished, as of the sponsor's last update on 13 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 4 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 NCT05002270, which also lists 1 linked publication.

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 Jan 2026.

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