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Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)

8 september 2026 bijgewerkt door: Genmab

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This Phase 3, randomized, open-label, global trial is designed to assess the efficacy and safety of petosemtamab plus investigator's choice (IC) chemotherapy (fluorouracil + leucovorin (calcium folinate) + oxaliplatin [mFOLFOX6] or fluorouracil + leucovorin (calcium folinate) + irinotecan [FOLFIRI]) versus standard of care (SOC) (ie, cetuximab + IC chemotherapy [mFOLFOX6 or FOLFIRI]) as 1L therapy in participants with unresectable or metastatic left-sided colorectal cancer.

Studietype

Ingrijpend

Inschrijving (Geschat)

960

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Puerto Rico
    • PR
      • Manati, PR, Puerto Rico, 00674
        • Werving
        • PanOncology
  • Verenigde Staten
    • Georgia
      • Savannah, Georgia, Verenigde Staten, 31405
        • Werving
        • Low Country Cancer Care Associates_Savannah_1
      • Warner Robins, Georgia, Verenigde Staten, 31088
        • Werving
        • Central Georgia Cancer Care - Warner Robins Office
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46260
        • Werving
        • Hematology-Oncology of Indiana, P.C.
    • Missouri
      • Springfield, Missouri, Verenigde Staten, 65807
        • Werving
        • Oncology Hematology Associates - Springfield_Springfield_2
    • Washington
      • Olympia, Washington, Verenigde Staten, 98502
        • Werving
        • Vista Oncology

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Petosemtamab + IC Chemotherapy
Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
Geneesmiddel: Petosemtamab
Intravenous infusion
Geneesmiddel: FOLFIRI
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Geneesmiddel: mFOLFOX6
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Actieve vergelijker: Cetuximab + IC Chemotherapy
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
Geneesmiddel: FOLFIRI
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Geneesmiddel: mFOLFOX6
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Geneesmiddel: Cetuximab
Intravenous infusion

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Tijdsspanne: Up to approximately 35 months
Up to approximately 35 months
Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
Tijdsspanne: Up to approximately 35 months
Up to approximately 35 months

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Progression-free Survival after First Subsequent Therapy (PFS2)
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Curative Resection (R0) Rate
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Number of Participants with Adverse Events (AEs)
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
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
Tijdsspanne: Baseline up to approximately 62 months
Baseline up to approximately 62 months
Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Tijdsspanne: Baseline up to approximately 62 months
Baseline up to approximately 62 months
Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months
Overall Side Effect Burden, as Measured by EORTC Item 168
Tijdsspanne: Up to approximately 62 months
Up to approximately 62 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Genmab

Onderzoekers

  • Studie directeur: Study Official, Genmab

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 augustus 2026

Primaire voltooiing (Geschat)

1 juli 2029

Studie voltooiing (Geschat)

1 september 2031

Studieregistratiedata

Eerst ingediend

9 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GCT1158-08
  • 2026-525883-17 (Andere identificatie: EU CT Number)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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