This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.
1. Age ≥ 18 years.
Gastrointestinal tumors (e.g., gastric cancer, liver cancer, cholangiocarcinoma, pancreatic cancer, colorectal cancer, etc.);
Gynecological tumors (e.g., ovarian cancer, endometrial cancer, etc.);
Non-small cell lung cancer (NSCLC);
1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or participated in another clinical trial within 4 weeks prior to the first administration of the study drug, or within 4 weeks or 5 half-lives of the treatment drug (whichever is shorter).
2. Known symptomatic central nervous system or meningeal metastases, or other evidence of uncontrolled central nervous system or meningeal metastases, deemed unsuitable for enrollment by the investigator.
3. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigator).
4. Concurrent participation in another clinical trial, unless it is observational (non-interventional) or in the follow-up period of an interventional trial.
Single group
paclitaxel cationic liposomes
DrugPaclitaxel cationic liposomes is a modified new drug. In this study, administration is performed through arterial catheter infusion.
The incidence of dose-limiting toxicity (DLT)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(according to NCI-CTCAE 5.0)
AUC0-t
AUC0-∞
Cmax
Kel
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