drugset
drugset / Trial / NCT07815288

Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases

NCT07815288 ↗

Phase 2 Not yet recruiting 80 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelTreatment

Summary

This is a single-center, open-label, exploratory phase II trial to evaluate efficacy and safety of Retlirafusp alfa (PD-L1/TGF-βRII bispecific fusion protein) combined with standard first-line targeted-chemotherapy as conversion therapy in adult patients with initially unresectable microsatellite-stable (MSS/pMMR) colorectal adenocarcinoma liver metastases. Two pre-defined cohorts are enrolled: Cohort 1 for RAS/BRAF wild-type left-sided primary tumor (mFOLFOX6 + cetuximab + Retlirafusp alfa); Cohort 2 for RAS/BRAF-mutant or right-sided primary tumor (CAPEOX + bevacizumab + Retlirafusp alfa).

Timeline

Start
2026-09-30
Primary completion
2029-12-30
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Retlirafusp alfa Protein / enzyme biologic 1800 mg Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

colorectal adenocarcinoma