JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd.

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