JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials ID:NCT05002270
This study assesses the safety and tolerability of JAB-21822, alone and with cetuximab, in adults with advanced solid tumors with KRAS G12C mutation. Participants must have prior therapy, measurable lesions, and adequate organ function. JAB-21822 is given orally, while cetuximab is administered intravenously.
Patient Parameters
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Program Overview
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.
Eligibility Criteria
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
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