Status:
NOT_YET_RECRUITING
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
Lead Sponsor:
Biotheus Inc.
Conditions:
HCC
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.
Detailed Description
The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects. The second part is a phase II randomized, parallel-controlled, four-arm,...
Eligibility Criteria
Inclusion
- Voluntary participation in clinical studies;
- Male or female, aged ≥ 18 years;
- Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;
- Child-Pugh liver function score ≤7；
- No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
- At least 1 measurable lesion ；
- Adequate organ function；
- ECOG score of 0 to 1；
- Life expectancy ≥ 12 weeks;
Exclusion
- Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；
- History of serious allergic diseases；
- The toxicity of previous anti-tumor therapy has not been alleviated；
- History of severe cardiovascular diseases within 6 months;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- History of alcohol abuse, psychotropic substance abuse or drug abuse;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06584071
Start Date
December 1 2024
End Date
December 1 2027
Last Update
December 16 2024
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