Petosemtamab plus chemotherapy vs cetuximab plus chemotherapy in left-sided unresectable or metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, open-label study compares petosemtamab plus investigator's choice chemotherapy (mFOLFOX6 or FOLFIRI) versus cetuximab plus investigator's choice chemotherapy in first-line treatment of unresectable or metastatic left-sided colorectal cancer with KRAS/NRAS wild-type tumors. Participants receive treatment in 4-week cycles with regular safety and efficacy assessments, including blood tests and imaging. The study aims to determine if the petosemtamab combination can improve outcomes compared with the current standard of care. Enrollment is global, with site-level treatment selection and no placebo used. Duration of treatment varies by patient response and tolerability, continuing while the study remains open and conditions are met.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Histologically or cytologically confirmed left-sided colorectal adenocarcinoma that is unresectable or metastatic.
* Must have documented KRAS and NRAS wild type (wt) colorectal cancer (CRC), as determined by medical record of results from local testing or as assessed by central testing. Local testing must have been conducted in accordance with local guidelines using an Food and Drug Administration (FDA)-approved test or a laboratory-developed test that is validated in a Clinical Laboratory Improvement Amendments (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. Polymerase chain reaction (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.

Key Exclusion Criteria:

* BRAF mutation, and/or microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) and/or protocol specified tumor status as documented by local test results in the medical record or from central testing or known documented activating HRAS mutation identified prior to enrollment from local testing results in the medical record, if available.
* Prior exposure to any agents that target epidermal growth factor receptor (EGFR) (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy).
* Known complete dihydropyrimidine dehydrogenase (DPD) deficiency or known homozygous/compound heterozygous dihydropyrimidine dehydrogenase gene (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.
* Participants with non-colorectal adenocarcinomatous disease.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Where it's running

• Genesis Cancer Center
  Hot Springs, Arkansas, United States Recruiting
• Valkyrie Clinical Trials - Los Angeles
  Los Angeles, California, United States Recruiting
• Low Country Cancer Care Associates_Savannah_1
  Savannah, Georgia, United States Recruiting
• Central Georgia Cancer Care - Warner Robins Office
  Warner Robins, Georgia, United States Recruiting
• Hematology-Oncology of Indiana, P.C.
  Indianapolis, Indiana, United States Recruiting
• Oncology Hematology Associates - Springfield_Springfield_2
  Springfield, Missouri, United States Recruiting

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.