A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of Paclitaxel Cationic Liposome for Injection in the Treatment of Patients With Advanced Solid Tumors Via Transcatheter Arterial Infusion Therapy.
Overview
- Phase
- Phase 1
- Intervention
- paclitaxel cationic liposomes
- Conditions
- Advanced Solid Tumor
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The incidence of dose-limiting toxicity (DLT)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.
Detailed Description
This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of paclitaxel cationic liposomes for injection administered via transcatheter arterial infusion in the treatment of advanced solid tumors. Paclitaxel cationic liposomes will be administered via arterial infusion on the first day of each cycle, with each treatment cycle lasting 3 weeks. Eligible participants will receive 4-6 cycles of study treatment. Treatment may be terminated early in the event of the following: disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or any other circumstances meeting the criteria for treatment discontinuation (whichever occurs first).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years.
- •Histologically or cytologically diagnosed advanced solid tumors suitable for arterial infusion chemotherapy, including but not limited to the following types:
- •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);
- •Liver metastases.
- •According to RECIST 1.1, at least one measurable lesion in the arterial infusion area.
- •If life-threatening primary lesions are within the arterial infusion area, limited lesions outside the arterial infusion area at baseline are acceptable.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Life expectancy of at least 3 months.
Exclusion Criteria
- •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).
- •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.
- •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).
- •Concurrent participation in another clinical trial, unless it is observational (non-interventional) or in the follow-up period of an interventional trial.
- •Major surgery or invasive intervention within 28 days prior to the first dose.
- •Use of any anti-cancer herbal or traditional Chinese medicine approved by the National Medical Products Administration (NMPA) within 14 days prior to the first dose.
- •Known severe allergic reactions to the study drug or its components/excipients.
- •Active bacterial, fungal, or viral infections requiring intravenous antibiotic, antifungal, or antiviral treatment prior to the first dose. Participants receiving prophylactic infection treatment with no signs of active infection may be considered for enrollment.
- •History of immunodeficiency diseases, including positive HIV antibodies.
- •Hepatitis B surface antigen (HBsAg) positive with HBV DNA above the measurable limit or 1000 copies/mL (500 IU/mL) (whichever is lower), or HCV antibody positive with HCV RNA above the measurable limit or 1000 copies/mL (whichever is lower). Individuals whose levels are reduced to below the standard following antiviral treatment may be screened.
Arms & Interventions
Experimental arm
Patients with advanced solid tumors received arterial infusion chemotherapy with paclitaxel cationic liposomes, at a dosage range of 33 mg/m\^2 to 66 mg/m\^2.
Intervention: paclitaxel cationic liposomes
Outcomes
Primary Outcomes
The incidence of dose-limiting toxicity (DLT)
Time Frame: At the end of Cycle 1 ( each cycle is 21 days)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(according to NCI-CTCAE 5.0)
Time Frame: Up to approximately 3 years
Secondary Outcomes
- Cmax(At the end of Cycle 4 ( each cycle is 21 days))
- Kel(At the end of Cycle 4 ( each cycle is 21 days))
- Tmax(At the end of Cycle 4 ( each cycle is 21 days))
- Vd(At the end of Cycle 4 ( each cycle is 21 days))
- t1/2(At the end of Cycle 4 ( each cycle is 21 days))
- CL(At the end of Cycle 4 ( each cycle is 21 days))
- Overall response rate (ORR)(Up to approximately 3 years)
- Disease control rate (DCR)(Up to approximately 3 years)
- Duration of Response (DoR)(Up to approximately 3 years)
- Progression-Free-Survival (PFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
- AUC0-∞(At the end of Cycle 4 ( each cycle is 21 days))
- AUC0-t(At the end of Cycle 4 ( each cycle is 21 days))