JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

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

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).

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