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

January 10, 2026 updated by: Jacobio Pharmaceuticals Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinc
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinc
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinc
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation
Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D
Drug: JAB-21822 (KRAS G12C inhibitor)
Administered orally
Experimental: Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion
JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.
Drug: JAB-21822 (KRAS G12C inhibitor)
Administered orally
Experimental: Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansion
JAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity.
Drug: JAB-21822 (KRAS G12C inhibitor)
Administered orally
Drug: Cetuximab (EGFR inhibitor)
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Expansion phase: Duration of response ( DOR )
Time Frame: Up to 4 years
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.
Up to 4 years
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)
Dose Escalation and Dose Expansion phase: Number of participants with adverse events
Time Frame: Up to 4 years
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
Up to 4 years
Dose Expansion phase: Overall response rate (ORR)
Time Frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Up to 4 years - from baseline to RECIST confirmed Progressive Disease

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
Time Frame: Up to 4 years
Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples
Up to 4 years
Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)
Time Frame: Up to 4 years
AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples
Up to 4 years
Dose Escalation phase: Overall response rate (ORR)
Time Frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease
The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
Up to 4 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation phase: Duration of response ( DOR )
Time Frame: Up to 4 years
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.
Up to 4 years
Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR )
Time Frame: Up to 4 years
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1
Up to 4 years
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
Time Frame: Up to 4 years
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
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2021

Primary Completion (Actual)

February 12, 2025

Study Completion (Actual)

February 12, 2025

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAB-21822-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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