JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05490472

Patient View

This study assesses the safety and tolerability of JAB-2485, an orally administered Aurora A inhibitor, to establish the MTD and RP2D in advanced solid tumors. Eligible participants must have an ECOG status of 0 or 1, confirmed advanced solid tumors, and meet specific criteria for the Dose Expansion phase. They must also have adequate organ function and be refractory to existing therapies.

Patient Parameters

Program Overview

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

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).

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

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