> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-petosemtamab-plus-chemotherapy-versus-cetuximab-964c0b27-9b27-451c-956a-7c117ada623b > Record changed: 2026-11-04 # Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1) NCT07702032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) Participants 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) Lead sponsor Genmab Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) Start date 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Title and summary **Summary** The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Short title** Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Dates **Completion date** 2031-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **First posted** 2026-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Primary completion date** 2029-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Start date** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Size and sites **Participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Planned participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Lead sponsor** Genmab Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Identifiers **Registry ID** NCT07702032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **ClinicalTrials.gov ID** NCT07702032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Outcomes ### Primary outcomes 1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR) Timeframe: Up to approximately 35 months 2. Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR Timeframe: Up to approximately 35 months ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to approximately 62 months 2. Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR Timeframe: Up to approximately 62 months 3. Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR Timeframe: Up to approximately 62 months 4. Progression-free Survival after First Subsequent Therapy (PFS2) Timeframe: Up to approximately 62 months 5. Curative Resection (R0) Rate Timeframe: Up to approximately 62 months 6. Number of Participants with Adverse Events (AEs) Timeframe: Up to approximately 62 months 7. Change from Baseline in Symptoms and Functioning, as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire (QLQ)-F17 Timeframe: Baseline up to approximately 62 months 8. Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29 Timeframe: Baseline up to approximately 62 months 9. Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17 Timeframe: Up to approximately 62 months 10. Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29 Timeframe: Up to approximately 62 months 11. Overall Side Effect Burden, as Measured by EORTC Item 168 Timeframe: Up to approximately 62 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Sites - Genesis Cancer CenterHot Springs, United StatesRecruiting - Valkyrie Clinical Trials - Los AngelesLos Angeles, United StatesRecruiting - Low Country Cancer Care Associates\_Savannah\_1Savannah, United StatesRecruiting - Central Georgia Cancer Care - Warner Robins OfficeWarner Robins, United StatesRecruiting - Hematology-Oncology of Indiana, P.C.Indianapolis, United StatesRecruiting - Oncology Hematology Associates - Springfield\_Springfield\_2Springfield, United StatesRecruiting - Vista OncologyOlympia, United StatesRecruiting - PanOncologyManati, Puerto RicoRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## References ### Other registry identifiers - 2026-525883-17 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07702032) ## Related records ### Drugs (6) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin calcium](https://trialight.com/data/asset/leucovorin-calcium-8da292ca-1b92-4365-b525-77d897b1c096.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Petosemtamab](https://trialight.com/data/asset/petosemtamab-661ba63c-03d6-4a61-bfb8-83dbf0a9cf89.md) ### Lead sponsors (1) - [Genmab](https://trialight.com/data/company/genmab-484f57db-e23b-4014-8aee-65414839b80f.md) ### Targets (4) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [LGR5](https://trialight.com/data/target/lgr5-eb2cf1eb-2d55-5b2c-aad6-6bbd3e4b192d.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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