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)

Sponsor
Genmab
Study ID
NCT07775287
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Petosemtamab — DRUG
    Intravenous (IV) infusion.
  • Cetuximab — DRUG
    IV infusion.
  • Bevacizumab — DRUG
    IV infusion.
  • 5-FU — DRUG
    IV infusion.
  • Leucovorin (Calcium Folinate) — DRUG
    IV infusion.
  • Oxaliplatin — DRUG
    IV infusion.
  • Irinotecan — DRUG
    IV infusion.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Mar 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Petosemtamab + IC Chemotherapy (FOLFIRI or mFOLFOX6)
    Participants will receive petosemtamab 1500 milligrams (mg) once every 2 weeks (Q2W) + IC chemotherapy (FOLFIRI or mFOLFOX6) Q2W.
  • Active Comparator: Arm B: IC Cetuximab or Bevacizumab + IC Chemotherapy (FOLFIRI or mFOLFOX6)
    Participants will receive IC cetuximab 500 milligrams per meter squared (mg/m\^2) or bevacizumab 5 milligrams per kilogram (mg/kg) Q2W + IC chemotherapy (FOLFIRI or mFOLFOX6) Q2W.

Primary Outcome Measure

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 2.5 years ]

Central Contacts

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