JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

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)

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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)

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)

Drug: JAB-2485 (Aurora A inhibitor)