A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma

Biotheus Inc.9 sites in 1 country35 target enrollmentApril 22, 2022

Overview

Brief Summary

This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.

Detailed Description

PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.

Registry

clinicaltrials.gov

Start Date

April 22, 2022

End Date

June 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotheus Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
•Male or female aged \>= 18 years;
•HCC diagnosed by pathology or clinical;
•BCLC stage C or B (unresectable or/and not suitable for local therapy);
•Child-Pugh score \<= 7;
•ECOG performance status of 0 or 1.

Exclusion Criteria

•Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
•Symptomatic CNS metastases, not suitable for the study assessed by investigator;
•Evidence of major coagulopathy or other obvious risk of bleeding;
•Unable to accept enhanced imaging examination (CT or MRI) for any reason;
•History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
•Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
•Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
•Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
•Patients with psychiatric disorders or poor compliance;
•Women who are pregnant or breastfeeding;

Arms & Interventions

PM8002+FOLFOX-4

PM8002 20mg/kg Q2W day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Intervention: PM8002

PM8002+FOLFOX-4

PM8002 20mg/kg Q2W day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Intervention: FOLFOX regimen