This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.
Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
Male or non-pregnant, non-lactating female subjects age ≥18 years.
ECOG Performance Status 0~1.
Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
History of another malignancy
Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
Significant cardiovascular disease.
Known active HBV, HCV, AIDS-related illness.
Sequential
PRJ1-3024
DrugPRJ1-3024 is provided as capsules and is administered orally once a day.
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Safety listings and pharmacokinetic listings will be used for evaluation
Incidence of adverse events (AEs)
Characterized by type, seriousness, relationship to study treatment, timing, and severity.
Pharmacokinetic parameter# Accumulation ratio
to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration
Objective response rate (ORR)
estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Duration of response (DOR)
defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.
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