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
- Trial code
- 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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData 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