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
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