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Not yet taking people in DenmarkPhase 3

Tests petosemtamab with chemotherapy against cetuximab in left-sided colorectal cancer

Compares petosemtamab plus chemotherapy with cetuximab plus chemotherapy in adults with advanced left-sided colorectal cancer.

Key facts

Who runs it
Genmab A/S
Where
Aalborg, Aarhus N, Copenhagen Oe, Odense C, and Vejle, DenmarkSee the 5 sitesAlso in 13 other countries, 108 sites
Registry title
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer.
Status
Not yet recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
17 Aug 2026
Expected to end
30 Sept 2031
Type of study
Interventional
Record updated
13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with left-sided colorectal cancer that cannot be removed by surgery or has spread, and who have not yet had drug treatment for it. The tumour must have normal (wild-type) KRAS and NRAS genes.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Left-sided colorectal adenocarcinoma that is unresectable (cannot be removed by surgery) or metastatic (has spread).
Earlier treatment
No earlier systemic (whole-body) drug therapy for unresectable or metastatic colorectal cancer.
Biomarker or test result
KRAS and NRAS wild-type (no change in these genes), shown by a next-generation sequencing (NGS) test of tumour tissue. PCR-based tests, Sanger sequencing and pyrosequencing results are not allowed.

Main reasons for not taking part

  • Known past or current right-sided colorectal cancer
  • BRAF V600 mutation, MSI-H/dMMR, or ERBB2/HER2 positive or amplified tumour, or a known activating HRAS mutation
  • Earlier treatment with any drug that targets EGFR
  • Known complete DPD deficiency or DPYD variants with complete loss of DPD activity
  • For FOLFIRI: known UGT1A1*28 or *6 variants as described in the record

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Histologically or cytologically confirmed left-sided colorectal adenocarcinoma that is unresectable or metastatic
  • Must have documented KRAS and NRAS wt CRC, as determined by medical record of results from local testing. Local testing must have been conducted in accordance with local guidelines using an FDA-approved test or a laboratory-developed test that is validated in a CLIA-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States). Next-generation sequencing (NGS)- based test results from tumor tissue are required for determining eligibility. PCR-based tests, sanger sequencing, or pyrosequencing test results are not allowed
  • Has not received any prior systemic therapy for unresectable or metastatic CRC
  • Must be eligible for treatment with mFOLFOX6 (if assigned to receive mFOLFOX6) or FOLFIRI (if assigned to receive FOLFIRI) according to local regulatory approvals and SOC guidelines. Note: Other protocol-defined Inclusion criteria may apply

Who cannot take part

  • Known prior or current right-sided CRC
  • BRAF V600 mutation (eg, V600E), and/or[AY9.1][JB9.2] MSI-H/dMMR and/or ERBB2/HER2 positive/amplified tumor status as documented by local test results in the medical record or known documented activating HRAS mutation identified prior to enrollment from local testing results in the medical record, if available
  • Participants with non-colorectal adenocarcinomatous disease. Note: Other protocol-defined Exclusion criteria may apply
  • Prior exposure to any agents that target EGFR (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy)
  • Known complete DPD deficiency or known homozygous/compound heterozygous DPYD variants associated with complete loss of DPD activity. Testing for DPD deficiency should be performed per local guidelines
  • For a participant who is to receive FOLFIRI: known to be homozygous for the UGT1A1*28 or *6 alleles or compound or double heterozygous for the UGT1A1*28 and *6 alleles. Testing for UGT1A1 should be done in accordance with local guidelines

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
  • Has a test shown that your tumour is 'MSI-high' or 'dMMR'?

Where in Denmark

Also in 13 other countries, 108 sites

  • Region NordjyllandAalborg, DenmarkNot yet recruiting
  • Region MidtjyllandAarhus N, DenmarkNot yet recruiting
  • Region HovedstadenCopenhagen Oe, DenmarkNot yet recruiting
  • Region SyddanmarkOdense C, DenmarkNot yet recruiting
  • Lillebaelt HospitalVejle, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

Determine the clinical efficacy of petosemtamab vs cetuximab, administered in combination with IC chemotherapy (mFOLFOX6 or FOLFIRI), as 1L therapy in participants with KRAS/NRAS/BRAF wt, unresectable or metastatic LS-CRC.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer.
Plain-language title
Tests petosemtamab with chemotherapy against cetuximab in left-sided colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2026-525883-17-00, who can take part
Record updated
13 November 2026
Under construction, not live – Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer. (2026-525883-17-00) – Frontlight Research