TrialPath
Recruiting

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

NCT05490472 · Jacobio Pharmaceuticals Co., Ltd.
In plain English

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Official title
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
About this study
The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).
Eligibility 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
Study design
Enrollment target: 102 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-12-20
Estimated completion: 2027-08
Last updated: 2026-01-09
Interventions
Drug: JAB-2485 (Aurora A inhibitor)Drug: JAB-2485 (Aurora A inhibitor)
Primary outcomes
  • Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) (First 21 days of Cycle 1)
  • Dose Escalation phase: Number of participants with adverse events (AEs) (Up to 3 years)
  • Dose Expansion phase: Objective Response Rate (ORR) (Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD))
Sponsor
Jacobio Pharmaceuticals Co., Ltd. · industry
Contacts & investigators
ContactJacobio Pharmaceuticals · contact · clinicaltrials@jacobiopharma.com · (781) 918-6670
All locations (8)
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
University of Utah Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Cancer Hospital Chinese Academy of Medical SciencesRecruiting
Beijing, Beijing Municipality, China
Peking University Third HospitalRecruiting
Beijing, Beijing Municipality, China
Jilin Cancer HospitalRecruiting
Changchun, Jilin, China
Shandong Cancer HospitalRecruiting
Jinan, Shandong, China
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors · TrialPath