drugset / Trial / NCT07775287

Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)

NCT07775287 ↗

Phase 3 Recruiting 600 enrolled Genmab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer that has recurred after previous treatment and that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or doctor's choice of standard-of-care (SOC) cetuximab or bevacizumab + chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Timeline

Start
2026-10-07
Primary completion
2029-03-30
Completion
2030-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Comparator Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Petosemtamab Monoclonal antibody 1500 mg Intravenous
Background Irinotecan Small molecule — Intravenous
Background Leucovorin Small molecule — Intravenous
Background Oxaliplatin Small molecule — Intravenous
Background fluorouracil Small molecule — Intravenous

Indications