Evaluating JAB-21822 for Advanced Solid Tumors with KRAS G12C Mutation
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 testing a new drug called JAB-21822 to see if it can help adults with advanced solid tumors that have a specific mutation, including lung and colorectal cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. Industry-sponsored |
| Drugs / interventions | cetuximab |
| Locations | 4 sites (Phoenix, Arizona and 3 other locations) |
| Trial ID | NCT05002270 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of JAB-21822, a KRAS G12C inhibitor, in adult patients with advanced solid tumors, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The trial consists of a dose escalation phase to determine the maximum tolerated dose (MTD) and a dose expansion phase to assess the preliminary antitumor activity of JAB-21822 alone and in combination with cetuximab. Participants must have previously received standard therapy and have measurable lesions as defined by RECIST criteria.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced solid tumors confirmed to have the KRAS G12C mutation who have received at least one prior treatment.
Not a fit: Patients with brain or spinal metastases, active infections, or severe uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors harboring the KRAS G12C mutation.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 3 other locations
- Mayo Clinc — Phoenix, Arizona, United States (Not_yet_recruiting)
- Mayo Clinc — Scottsdale, Arizona, United States (Not_yet_recruiting)
- Mayo Clinc — Jacksonville, Florida, United States (Not_yet_recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Huiqiang Wang, PhD
- Email: Huiqiang.wang@jacobiopharma.com
- Phone: 86 10 56315466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.