JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Status: active

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

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

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

Additional locations may be listed on ClinicalTrials.gov for NCT05490472.

State:

Siteman Cancer Center at Washington University

Status: Active

Name Not Available

Case Comprehensive Cancer Center

Status: Approved

Name Not Available

Huntsman Cancer Institute/University of Utah

Status: Active

Name Not Available

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).

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