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

  • STATUS
    Recruiting
  • End date
    Jul 16, 2025
  • participants needed
    100
  • sponsor
    Jacobio Pharmaceuticals Co., Ltd.
Updated on 16 September 2021
measurable disease
KRAS
EGFR
cetuximab

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.

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.

Details
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

Eligibility

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.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note