Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma

Sponsor
Polaris Group
Study ID
NCT05317819
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ADI-PEG20 — DRUG
    Treatment for hepatocellular carcinoma
  • Placebo — OTHER
    Treatment for hepatocellular carcinoma

Study Details

Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC

Key Dates

Start date
Mar 14, 2022
Status verified
Nov 2025
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: ADI-PEG 20
    Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)
  • Placebo Comparator: Drug: Placebo
    Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Approximately 18 months ]

Central Contacts

Related Studies