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

Overview

About this study

The primary objectives of this study are to evaluate the overall safety and tolerability of JAB-21822 monotherapy, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) of JAB-21822 and in combination with cetuximab administered by prescription (QD) in participants with relapsed or refractory solid tumors with KRAS G12C mutation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Alex Adjei, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vinicius Ernani, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20521319

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