Evaluating JAB-2485 for Advanced Solid Tumors
A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors
PHASE1; PHASE2 · Jacobio Pharmaceuticals Co., Ltd. · NCT05490472
This study is testing a new drug called JAB-2485 to see if it is safe and can help adults with advanced solid tumors, like certain types of breast cancer and lung cancer, who have already tried other treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. (industry) |
| Locations | 8 sites (Detroit, Michigan and 7 other locations) |
| Trial ID | NCT05490472 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of JAB-2485, an Aurora A inhibitor, in adult patients with advanced solid tumors. The trial consists of a Dose Escalation phase to determine the maximum tolerated dose (MTD) and a Dose Expansion phase to evaluate the preliminary antitumor activity at the recommended Phase 2 dose (RP2D). Participants must have confirmed metastatic or locally advanced solid tumors and must have previously been treated with existing therapies. The study focuses on specific tumor types, including ER+ breast cancer, triple negative breast cancer, ARID1A mutant tumors, and small cell lung cancer.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced solid tumors who have not responded to or are intolerant of existing therapies.
Not a fit: Patients with central nervous system metastases or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies involving Aurora A inhibitors have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Must be able to provide an archived tumor sample * Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor * Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated * Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition * Must have at least 1 measurable lesion per RECIST v1.1 * Must have adequate organ functions * Must be able to swallow and retain orally administered medication Exclusion Criteria: * Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days * Active infection requiring systemic treatment within 7 days * Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV * Any severe and/or uncontrolled medical conditions * left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA) * QT interval using Fridericia's formula (QTcF) interval \>470 msec * Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities * Clinically significant eye disorders
Where this trial is running
Detroit, Michigan and 7 other locations
- Henry Ford Health System — Detroit, Michigan, United States (RECRUITING)
- Washington University — St Louis, Missouri, United States (RECRUITING)
- Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (RECRUITING)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)
- Jilin Cancer Hospital — Changchun, Jilin, China (RECRUITING)
- Shandong Cancer Hospital — Jinan, Shandong, China (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.
Conditions: Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation, Small Cell Lung Cancer, SCLC, Aurora A inhibitor