Menu
Recruiting NCT05490472

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Solid Tumors ER+ Breast Cancer Triple Negative Breast Cancer, TNBC ARID1A Gene Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB-2485 (Aurora A inhibitor), JAB-2485 (Aurora A inhibitor).
Who it may be relevant to
Registry conditions: Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Detailed description

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).

Interventions

  • Drug JAB-2485 (Aurora A inhibitor)
    Administered orally
  • Drug JAB-2485 (Aurora A inhibitor)
    Administered orally

Primary outcome measures

  • Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) [Time frame: First 21 days of Cycle 1]
  • Dose Escalation phase: Number of participants with adverse events (AEs) [Time frame: Up to 3 years]
  • Dose Expansion phase: Objective Response Rate (ORR) [Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)]
  • Dose Expansion phase: Duration of Response (DOR) [Time frame: Up to 3 years]
Secondary outcome measures (12)
  • Dose Escalation phase: Objective Response Rate (ORR) [Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)]
  • Dose Escalation and Dose Expansion phase: Time to response (TTR) [Time frame: Up to 3 years]
  • Dose Escalation phase: Duration of Response (DOR) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Ctrough [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Area under the curve (AUC) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: half-life (t½) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: total body clearance [Time frame: Up to 3 years]
  • Dose Expansion phase: Progression Free Survival (PFS) [Time frame: Up to 3 years]
  • Dose Expansion Phase 2a: Overall Survival (OS) [Time frame: Up to 3 years]
  • Dose Expansion phase: Disease Control Rate (DCR) [Time frame: Up to 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Henry Ford Health System — Detroit
  • Washington University — St Louis
  • Mary Crowley Cancer Research — Dallas
  • University of Utah Huntsman Cancer Institute — Salt Lake City
China · 4 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Peking University Third Hospital — Beijing
  • Jilin Cancer Hospital — Changchun
  • Shandong Cancer Hospital — Jinan

Identifiers

NCT: NCT05490472 · JAB-2485-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗