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Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)

StatusRecruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 6 to 8 Eligibility criteria expanded, about 9 words · Study description revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Study description revised
  2. Trial sites expanded: 2 → 6 locationsv5
  3. Study sites: 1 to 2 Start date changed from estimate of Aug 2026 to Aug 11, 2026 · Study title expanded, about 1 wordv4 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2026 to Aug 11, 2026
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jul 2026 to Aug 2026v3
  5. Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Genmab
45 trials monitored
See 3 trials at risk
Colorectal Cancer
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 located on the left side of the colon 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 standard-of-care cetuximab + doctor's choice of 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 NCT07702032
Lead Sponsor Genmab
Conditions Left-sided Colorectal Cancer
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov