An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
Subjects who voluntarily signed a written informed consent form before the start of the study;
Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v6.0) [except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk];
Women during pregnancy or breastfeeding;
Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA > ULN;;
Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;
Aallergy to the active ingredient or excipients of the investigational medicinal product;
Ganzhou Hemay Pharmaceutical Co., Ltd
Lead sponsor