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

  • End date
    Jul 16, 2025
  • participants needed
  • sponsor
    Jacobio Pharmaceuticals Co., Ltd.
Updated on 16 September 2021
measurable disease


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.


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.

Condition Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Advanced Malignant Solid Tumor, colorectal cancers, nsclc
Treatment JAB-21822 (KRAS G12C inhibitor), Cetuximab (EGFR inhibitor)
Clinical Study IdentifierNCT05002270
SponsorJacobio Pharmaceuticals Co., Ltd.
Last Modified on16 September 2021


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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