NCT05733598

Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC

A Phase 2, Open-label, Multicenter Study Investigating RP2 Oncolytic Immunotherapy in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable, Recurrent and/or Metastatic Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Replimune, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and/or metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC.

Detailed description

This is a Phase 2, open-label, multicenter study evaluating RP2 oncolytic immunotherapy in combination with atezolizumab plus bevacizumab and RP2 monotherapy as second-line treatment in patients with locally advanced unresectable, recurrent, and/or metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC (Cohort 3). The study periods will consist of Screening, Treatment, and Follow-Up: * 28-day Screening Period * Treatment Period * HCC Cohorts (Cohort 1a, 1b, and 2): First tumor assessment at 10 weeks (± 3 days) from the date of the first dose of study treatment and second assessment 9 weeks (± 3 days) later; subsequent assessments every 8 weeks (Q8W) * BTC cohort (Cohort 3): First tumor assessment at 8 weeks (± 3 days) from the date of the first dose of study treatment; subsequent assessments Q8W * Safety Follow-Up * 30 days and 60 days after the last dose of RP2 * 135 days after the last doses of atezolizumab and bevacizumab * 135 days after the last dose of durvalumab * Efficacy Follow-Up: \- HCC and BTC Cohorts: Imaging and tumor assessments every 12 weeks * Survival Follow-Up * Survival information will be collected over the phone every 3 months for up to 3 years from the patient's first RP2 dose or until death, whichever occurs first

Conditions

• Hepatocellular Carcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
BIOLOGICAL	RP2	Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
BIOLOGICAL	Bevacizumab	Anti-VEGF therapy.
BIOLOGICAL	Atezolizumab	Anti-PD-L1 monoclonal antibody.
BIOLOGICAL	Durvalumab	Anti-PD-L1 monoclonal antibody
BIOLOGICAL	RP2 Monotherapy	Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-12-01
• Completion: 2028-07-01
• First posted: 2023-02-17
• Last updated: 2026-04-02

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study