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NCT05490472PHASE1, PHASE2Recruiting

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Jacobio Pharmaceuticals Co., Ltd.

Start Date

12/20/2022

Completion Date

8/1/2027

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

JAB-2485 (Aurora A inhibitor)

DRUG

JAB-2485 (Aurora A inhibitor)

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Conditions

Solid TumorsER+ Breast CancerTriple Negative Breast Cancer, TNBCARID1A Gene MutationSmall Cell Lung Cancer, SCLC

Locations

Henry Ford Health System

Detroit, Michigan 48202

United States

Washington University

St Louis, Missouri 63110

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100101

China

Peking University Third Hospital

Beijing, Beijing Municipality 100101

China

Jilin Cancer Hospital

Changchun, Jilin 130000

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China