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JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

J

Jacobio Pharmaceuticals

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Triple Negative Breast Cancer, TNBC
ARID1A Gene Mutation
Small Cell Lung Cancer, SCLC
Solid Tumors
ER+ Breast Cancer

Treatments

Drug: JAB-2485 (Aurora A inhibitor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05490472
JAB-2485-1001

Details and patient eligibility

About

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

Full 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).

Enrollment

102 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

102 participants in 2 patient groups

JAB-2485 monotherapy, Phase 1, Dose Escalation
Experimental group
Description:
Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.
Treatment:
Drug: JAB-2485 (Aurora A inhibitor)
JAB-2485 monotherapy, Phase 2a, Dose Expansion
Experimental group
Description:
JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.
Treatment:
Drug: JAB-2485 (Aurora A inhibitor)

Trial contacts and locations

5

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Central trial contact

Zhiwen He; Jacobio Pharmaceuticals

Data sourced from clinicaltrials.gov

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