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.
Zhuhai Yufan Biotechnologies Co., Ltd
Lead sponsor