Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer.
Key facts
- Where
- Budapest VIII, Budapest XII, Debrecen és Kecskemét, MagyarországSee the 4 sites
- Phase
- 3. fázis
Could this be for you?
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 Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországToborzás még nem indult
- Orszagos Onkologiai IntezetBudapest XII, MagyarországToborzás még nem indult
- University of DebrecenDebrecen, MagyarországToborzás még nem indult
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, MagyarországToborzás még nem indult
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?
Trial details
- Who runs it
- Genmab A/S
- Trial code
- EU 2026-525883-17-00
- Record updated
- 2026. október 26.
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: 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.