drugset / Trial / NCT05864105

PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma

NCT05864105

Phase 2 Completed 35 enrolled BioNTech SE
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-04-22
Primary completion
2025-07-24
Completion
2025-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Pumitamig Protein / enzyme biologic 20 mg/kg
Background Leucovorin Small molecule 200 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous