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
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
Sequential
JAB-2485 (Aurora A inhibitor)
DrugAdministered orally
JAB-2485 (Aurora A inhibitor)
DrugAdministered orally
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
A DLT is defined as an adverse event (AE) regardless of attribution unless clearly related to underlying disease or extraneous cause during the first 21 days of Cycle 1 (DLT observation period).
Dose Escalation phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Dose Expansion phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1
Dose Expansion phase: Duration of Response (DOR)
DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Dose Escalation phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1
Dose Escalation and Dose Expansion phase: Time to response (TTR)
TTR is defined as the interval of time between the date of first treatment to the first documented response (CR or PR) as determined by investigator assessment per RECIST v1.1
Dose Escalation phase: Duration of Response (DOR)
DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)
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