An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

January 24, 2024

Primary Completion Date

October 1, 2025

Study Completion Date

December 31, 2025

Conditions
Hepatocellular CarcinomaIntrahepatic Cholangiocarcinoma
Interventions
DRUG

VG161

"Name: VG161 (Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) Concentration/Content: ≥1×107 PFU/mL; 1.0 mL/vial. Actual titer will be recorded on Certificate of Analysis.~Composition: VG161,50 mM Tris-HCl, 150mM NaCl, \<5% glycerol Route of Administration: Intratumoral injection or image guided intratumoral injections."

DRUG

Nivolumab Injection [Opdivo]

immunotherapy treatment

Trial Locations (3)

32224

RECRUITING

Mayo Clinic Florida, Jacksonville

55905

RECRUITING

Mayo Clinic, Rochester

85054

RECRUITING

Mayo Clinic, Phoenix

All Listed Sponsors
lead

Virogin Biotech Canada Ltd

INDUSTRY