2026-525883-17-00Not yet recruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer.
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 17 Aug 2026
- Lead sponsor
- Genmab A/S
- Diseases
- Colorectal cancer
- EU CT number
- 2026-525883-17-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 450
- 110 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants with non-colorectal adenocarcinomatous disease. Note: Other protocol-defined Exclusion criteria may apply.
Lab values
- Prior exposure to any agents that target EGFR (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (110)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH | Linz | Austria | Not yet recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH | Salzburg | Austria | Not yet recruiting |
| Institut Jules Bordet | Anderlecht | Belgium | Not yet recruiting |
| Imelda | Bonheiden | Belgium | Not yet recruiting |
| Grand Hopital de Charleroi | Charleroi | Belgium | Not yet recruiting |
| Chu Helora | La Louvière | Belgium | Not yet recruiting |
| Vivalia | Libramont-Chevigny | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Namur | Belgium | Not yet recruiting |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Not yet recruiting |
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Yvoir | Belgium | Not yet recruiting |
| University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD | Sofia | Bulgaria | Not yet recruiting |
| MBAL Sveta Marina EAD | Varna | Bulgaria | Not yet recruiting |
| Fakultni nemocnice Brno | Brno | Czechia | Not yet recruiting |
| Masarykuv Onkologicky Ustav | Brno-Stred | Czechia | Not yet recruiting |
| NH Hospital a.s. | Hořovice | Czechia | Not yet recruiting |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | Not yet recruiting |
| Fakultni Nemocnice Motol a Homolka | Prague | Czechia | Not yet recruiting |
| Katholisches Klinikum Bochum gGmbH | Bochum | Germany | Not yet recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Not yet recruiting |
| Marien Hospital Duesseldorf GmbH | Duesseldorf | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Not yet recruiting |
| Universitaetsmedizin Goettingen | Goettingen | Germany | Not yet recruiting |
| Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie | Hamburg | Germany | Not yet recruiting |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | Germany | Not yet recruiting |
| Universitaet Leipzig | Leipzig | Germany | Not yet recruiting |
| LMU Klinikum Muenchen AöR | Munich | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Not yet recruiting |
| ohO Research GmbH | Oldenburg in Holstein | Germany | Not yet recruiting |
| Region Nordjylland | Aalborg | Denmark | Not yet recruiting |
| Region Syddanmark | Odense C | Denmark | Not yet recruiting |
| Institut Catala d'Oncologia | Badalona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
| Hospital del Mar | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Not yet recruiting |
| Micancer Center S.L.P. | Barcelona | Spain | Not yet recruiting |
| Hospital General Universitario de Elche | Elche | Spain | Not yet recruiting |
| Hospital Universitario del Vinalopo | Elche | Spain | Not yet recruiting |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida | Lleida | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Not yet recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Not yet recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Not yet recruiting |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Not yet recruiting |
| Clínica Universidad de navarra | Pamplona | Spain | Not yet recruiting |
| Hospital Universitario de Navarra | Pamplona | Spain | Not yet recruiting |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Spain | Not yet recruiting |
| Hospital Universitario de Torrejon | Torrejón de Ardoz | Spain | Not yet recruiting |
| Consorcio Hospital General Universitario de Valencia | Valencia | Spain | Not yet recruiting |
| Fundación Instituto Valenciano de Oncología | Valencia | Spain | Not yet recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Not yet recruiting |
| Sainte Catherine Institut Du Cancer Avignon-Provence | Avignon Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Régional et Universitaire de Brest | Brest | France | Not yet recruiting |
| Centre Francois Baclesse | Caen Cedex 5 | France | Not yet recruiting |
| Centr Georges Francois Leclerc | Dijon | France | Not yet recruiting |
| Polyclinique De Blois | La Chaussee St Victor | France | Not yet recruiting |
| Centre Leon Berard | Lyon | France | Not yet recruiting |
| Institut Paoli-Calmettes | Marseille | France | Not yet recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Not yet recruiting |
| Institut Regional Du Cancer De Montpellier | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Not yet recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Not yet recruiting |
| Institut Godinot | Reims | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Not yet recruiting |
| Institut De Cancerologie De L Ouest | Saint-Herblain Cedex | France | Not yet recruiting |
| Groupe Hospitalier Saint Vincent | Strasbourg | France | Not yet recruiting |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Not yet recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Chaïdári | Greece | Not yet recruiting |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. | Cholargos | Greece | Not yet recruiting |
| General University Hospital Of Patras | Patras | Greece | Not yet recruiting |
| St. Luke's Hospital S.A. | Thessaloniki | Greece | Not yet recruiting |
| Genesis Idiotiki Geniki Maieftiki Gynaikologiki Kliniki S.A. | Thessaloniki | Greece | Not yet recruiting |
| Semmelweis University | Budapest VIII | Hungary | Not yet recruiting |
| Orszagos Onkologiai Intezet | Budapest XII | Hungary | Not yet recruiting |
| University of Debrecen | Debrecen | Hungary | Not yet recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz | Kecskemét | Hungary | Not yet recruiting |
| Azienda Ospedaliero-Universitaria delle Marche | Ancona | Italy | Not yet recruiting |
| AORN San Giuseppe Moscati Avellino | Avellino | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Not yet recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l | Meldola | Italy | Not yet recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli | Naples | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Not yet recruiting |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna | Italy | Not yet recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Not yet recruiting |
| Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | Not yet recruiting |
| Pia Fondazione Di Culto E Religione Card G Panico | Tricase | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale | Udine | Italy | Not yet recruiting |
| Rijnstate Ziekenhuis Stichting | Arnhem | Netherlands | Not yet recruiting |
| Ikazia Ziekenhuis | Rotterdam | Netherlands | Not yet recruiting |
| Stichting Elisabeth-TweeSteden Ziekenhuis | Tilburg | Netherlands | Not yet recruiting |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy | Bydgoszcz | Poland | Not yet recruiting |
| Pratia S.A. | Cracow | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Not yet recruiting |
| Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Opole | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Not yet recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. | Siedlce | Poland | Not yet recruiting |
| Aidport sp z o.o. | Skorzewo | Poland | Not yet recruiting |
| Futuremeds Sp. z o.o. | Warsaw | Poland | Not yet recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy | Warsaw | Poland | Not yet recruiting |
| Pratia S.A. | Wroclaw | Poland | Not yet recruiting |
| Institutul Clinic Fundeni | Bucharest | Romania | Not yet recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. | Craiova | Romania | Not yet recruiting |
| Spitalul Municipal Dr. Alexandru Simionescu Hunedoara | Hunedoara | Romania | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.