Status:
UNKNOWN
A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.
Eligibility Criteria
Inclusion
- Signed informed consent from the patient；
- ECOG performance status of 0 or 1;
- Histologically/cytologically confirmed diagnosis of advanced HCC;
- Adequate washout period for previous anti-tumor therapy;
- Measurable disease according to RECIST v1.1;
- Life expectancy ≥ 12 weeks;
- Adequate organ function;
- Child-Pugh grade A or partial grade B; BCLC stage B or C;V
Exclusion
- Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of \> 360 mg/m2 ;
- Any drug-related adverse event derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects, that has not recovered to grade1 or less;
- Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.);
- Any history of other malignancy within 5 years;
- Untreated hepatitis infection;
- HIV positive;
- History of liver transplantation, severe cirrhosis, hepatic encephalopathy;
- Inadequate cardiac function;
- Pregnant or lactating women.
Key Trial Info
Start Date :
June 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04331743
Start Date
June 5 2021
End Date
June 1 2023
Last Update
June 16 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.