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

Sponsor
Biotheus Inc.
Study ID
NCT05864105
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — BIOLOGICAL
    PM8002 20mg/kg Q2W
  • FOLFOX regimen — DRUG
    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 \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Study Details

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.

Key Dates

First listed
May 18, 2023
Start date
Apr 22, 2022
Status verified
Jul 2025
Primary completion
Jul 24, 2025
Completion
Jul 24, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to approximately 2 years ]

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