To hear about similar clinical trials, please enter your email below
Trial Title:
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
NCT ID:
NCT06584071
Condition:
HCC
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Bevacizumab
Atezolizumab
Conditions: Keywords:
first line
HCC
PM1009
PM8002
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
PM8002 via IV infusion, Q3W
Arm group label:
Cohort 1- combination treatment
Arm group label:
Cohort 2- combination treatment
Arm group label:
Cohort 3- monotherapy
Intervention type:
Drug
Intervention name:
PM1009
Description:
PM8002 via IV infusion, Q3W
Arm group label:
Cohort 1- combination treatment
Arm group label:
Cohort 2- combination treatment
Intervention type:
Drug
Intervention name:
atezolizumab
Description:
atezolizumab,1200mg, via IV infusion, Q3W
Arm group label:
Cohort 4
Intervention type:
Drug
Intervention name:
bevacizumab
Description:
bevacizumab,15mg/kg, via IV infusion, Q3W
Arm group label:
Cohort 4
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, open-label
study, which is planned to enroll approximately 120 subjects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation in clinical studies;
2. Male or female, aged ≥ 18 years;
3. Pathologically or clinically confirmed (according to AASLD), unresectable locally
advanced and/or metastatic HCC;
4. Child-Pugh liver function score ≤7；
5. No prior systemic therapy for locally advanced or metastatic and/or unresectable
HCC；
6. At least 1 measurable lesion ；
7. Adequate organ function；
8. ECOG score of 0 to 1；
9. Life expectancy ≥ 12 weeks;
Exclusion Criteria:
1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and
other components；
2. History of serious allergic diseases；
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. History of severe cardiovascular diseases within 6 months;
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ
transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06584071
