Ligufalimab and Cadonilimab in Advanced Liver Cancers

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06789848
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma
  • Biliary Tract Cancer
  • Refractory Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

  • Ligufalimab — DRUG
    Ligufalimab (AK117) 45 mg/kg IV over 120 minutes on Day 1 every 3 weeks
  • Cadonilimab — DRUG
    Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks

Study Details

The goal of this clinical trial is to find out if the combination of Ligufalimab and Cadonilimab are effective in treating advanced hepatobiliary cancers that have failed prior therapy.

Key Dates

Start date
Feb 18, 2025
Status verified
Feb 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Hepatocellular carcinoma (HCC) / Liver Cancer
    Ligufalimab and Cadonilimab are given via intravenous (through the veins) infusion in the clinic. Each clinic visit will last 4-5 hours. Infusions of study drugs will be given on the first day of every 21-day cycle. Study medications will continue if evaluations show that disease has not gotten worse.
  • Experimental: Cohort B: Bile duct cancer
    Ligufalimab and Cadonilimab are given via intravenous (through the veins) infusion in the clinic. Each clinic visit will last 4-5 hours. Infusions of study drugs will be given on the first day of every 21-day cycle. Study medications will continue if evaluations show that disease has not gotten worse.

Primary Outcome Measure

Objective Response rate of combination ligufalimab and cadonilimab [ Time Frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Carrie Manwaring
[email protected]
214-648-7097

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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