Clinical trial · Interventional
JAB-2485 Activity in Adult Patients With 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
NCT05490472CI-TRIAL-00100519recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ARID1A Gene Mutation | — | UNRESOLVED | — |
| ER+ Breast Cancer | — | UNRESOLVED | — |
| Small Cell Lung Cancer, SCLC | Lung Small Cell Carcinoma | ALIAS | 0.85 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Triple Negative Breast Cancer, TNBC | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-2485 (Aurora A inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JAB-2485 monotherapy, Phase 1, Dose Escalation
- description
- Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.
- interventionNames
- Drug: JAB-2485 (Aurora A inhibitor)
- type
- EXPERIMENTAL
- label
- JAB-2485 monotherapy, Phase 2a, Dose Expansion
- description
- JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.
- interventionNames
- Drug: JAB-2485 (Aurora A inhibitor)
Primary outcomes (4)
- measure
- Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.