JAB-23E73 treatment for adults with advanced solid tumors that have KRAS changes
A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in Adult Patients With Advanced Solid Tumors With KRAS Alteration
This trial will try JAB-23E73, an oral pan-KRAS drug, to see if it is safe and helps adults with advanced solid tumors that carry KRAS mutations.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT06973564 on ClinicalTrials.gov |
What this trial studies
This is an open-label Phase 1/2a trial that gives JAB-23E73 as a single agent to adults with advanced or metastatic solid tumors harboring KRAS alterations. The study begins with a Phase 1a dose-escalation to define the maximum tolerated dose or preliminary recommended Phase 2 dose, then proceeds to Phase 1b dose-expansion and Phase 2a indication expansion across cohorts for colorectal cancer, pancreatic ductal adenocarcinoma, and other solid tumors. Key outcomes include safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity assessed by RECIST v1.1. Participants must be adults with measurable disease, ECOG 0–1, provide tumor tissue, and have not previously received KRAS-targeting or pan-KRAS inhibitors.
Who should consider this trial
Good fit: Adults (≥18) with histologically or cytologically confirmed locally advanced or metastatic solid tumors with KRAS alterations, measurable disease, ECOG 0–1, life expectancy ≥3 months, and able to provide an archived tumor sample are ideal candidates.
Not a fit: Patients who have primary central nervous system tumors, cannot swallow oral medication, have gastrointestinal conditions that impair drug absorption, or who previously received KRAS-targeting or pan-KRAS inhibitors are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, JAB-23E73 could provide a new targeted oral treatment option for patients with KRAS-mutated advanced solid tumors, including colorectal and pancreatic cancers.
How similar studies have performed: Selective KRAS G12C inhibitors have produced clinical responses in that subset, but pan-KRAS approaches are newer and less proven, so this strategy is relatively novel compared with single-variant KRAS inhibitors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent. * Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF). * Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions. * Patients must have KRAS alterations. * Participants are required to provide an archived tumor sample. * Patients with a life expectancy ≥3 months. * ECOG performance status score of 0 or 1. * Patients must have at least one measurable lesion as defined by RECIST v1.1. Exclusion Criteria: * Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug. * Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, or pan/multi-KRAS inhibitors. * Known serious allergy to JAB-23E73 or excipient. * Patients with primary central nervous system tumors. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention. * QT interval\>470 msec. * LVEF ≤50% assessed by ECHO or MUGA.
Where this trial is running
Rochester, Minnesota and 3 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Jacobio Pharmaceuticals
- Email: clinicaltrials@jacobiopharma.com
- Phone: (781) 918-6670
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.