A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC

Sponsor
Guangzhou Virotech Pharmaceutical Co., Ltd.
Study ID
NCT07589244
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • VRT106 — DRUG
    VRT106,Intravenous infusion
  • VRT106 in combination with camrelizumab and apatinib — DRUG
    VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
  • Investigator's Choice of Standard of Care — DRUG
    At the investigator's discretion

Study Details

This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).

Key Dates

First listed
May 15, 2026
Start date
May 13, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

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

Arms

  • Experimental: VRT106 Monotherapy
    VRT106
  • Experimental: VRT106 Combination
    VRT106 in combination with camrelizumab and apatinib
  • Active Comparator: Standard of Care
    Investigator's Choice of Standard of Care

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities [ Time Frame: Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106. ]

Central Contacts

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