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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)

StatusRecruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of Oct 15, 2026 to Oct 7, 2026
  2. Notable Start date pushed from Sep 15, 2026 to Oct 15, 2026 Trial sites expanded: 1 → 4 locations · Eligibility criteria expanded, about 10 words · Study description revised Show 3 more changesShow less
    • Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 10 words
    • Study description revised
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
45 trials monitored
See 3 trials at risk
2,920 trials monitored
See 132 trials at risk
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.
Trial Details
NCT Number NCT07775287
Lead Sponsor Genmab
Conditions Colorectal Cancer
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov