Trial intelligence / Profile preview

RP2 in Combination With Second-line Therapy in HCC and BTC

NCT05733598Phase 2

Key facts

Status: Recruiting
Start: Aug 2024
Primary completion: Dec 2027
Countries: 1
Sponsor: Replimune Group, Inc.
Modality: Gene Editing, Antibody Conjugates, Gene Silencing

Drugs: sturlimogene erparepvec
Conditions: hepatocellular carcinoma (HCC)biliary tract cancer (BTC)

Overview

Phase 2, open-label trial of sturlimogene erparepvec in hepatocellular carcinoma (HCC) and biliary tract cancer (BTC) (3 arms), sponsored by Replimune Group, Inc. Primary endpoint: Overall Response Rate up to 3 years. Started Aug 2024; status: recruiting.

Design

3 arms

Study design: Non-randomizedOpen-label

RP2+Bevacizumab and Atezolizumab
HCC Cohort 1a and 1b receiving RP2 + atezolizumab + bevacizumab
RP2 Monotherapy
HCC Cohort 2 receiving RP2 monotherapy
RP2+Durvalumab
BTC Cohort 3 receiving RP2 + durvalumab

Who it enrols

Adults with locally advanced unresectable, recurrent, and/or metastatic HCC or BTC who have progressed on prior specific systemic therapies, with adequate organ function and ECOG PS 0-1.

Endpoints

Primary

Overall Response Rateup to 3 years

Secondary

Treatment-Emergent Adverse Eventsup to 135 days
Overall Response Rate per HCC mRECISTup to 3 years
Duration of Responseup to 3 years

Beyond the preview

Go deeper on NCT05733598.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05733598.