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 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
960
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Genmab Trial Information
- Numéro de téléphone: +4570202728
- E-mail: clinicaltrials@genmab.com
Lieux d'étude
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PR
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Manati, PR, Porto Rico, 00674
- Recrutement
- PanOncology
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-
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Georgia
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Savannah, Georgia, États-Unis, 31405
- Recrutement
- Low Country Cancer Care Associates_Savannah_1
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Warner Robins, Georgia, États-Unis, 31088
- Recrutement
- Central Georgia Cancer Care - Warner Robins Office
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Indiana
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Indianapolis, Indiana, États-Unis, 46260
- Recrutement
- Hematology-Oncology of Indiana, P.C.
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Missouri
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Springfield, Missouri, États-Unis, 65807
- Recrutement
- Oncology Hematology Associates - Springfield_Springfield_2
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Washington
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Olympia, Washington, États-Unis, 98502
- Recrutement
- Vista Oncology
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Petosemtamab + IC Chemotherapy
Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
|
Intravenous infusion
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
|
|
Comparateur actif: Cetuximab + IC Chemotherapy
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
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Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Intravenous infusion
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Délai: Up to approximately 35 months
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Up to approximately 35 months
|
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Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
Délai: Up to approximately 35 months
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Up to approximately 35 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Overall Survival (OS)
Délai: Up to approximately 62 months
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Up to approximately 62 months
|
|
Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
Délai: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
Délai: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Progression-free Survival after First Subsequent Therapy (PFS2)
Délai: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Curative Resection (R0) Rate
Délai: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Number of Participants with Adverse Events (AEs)
Délai: 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
Délai: Baseline up to approximately 62 months
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Baseline up to approximately 62 months
|
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Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Délai: Baseline up to approximately 62 months
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Baseline up to approximately 62 months
|
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Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17
Délai: Up to approximately 62 months
|
Up to approximately 62 months
|
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Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Délai: Up to approximately 62 months
|
Up to approximately 62 months
|
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Overall Side Effect Burden, as Measured by EORTC Item 168
Délai: Up to approximately 62 months
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Up to approximately 62 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Study Official, Genmab
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 août 2026
Achèvement primaire (Estimé)
1 juillet 2029
Achèvement de l'étude (Estimé)
1 septembre 2031
Dates d'inscription aux études
Première soumission
9 juillet 2026
Première soumission répondant aux critères de contrôle qualité
9 juillet 2026
Première publication (Réel)
14 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GCT1158-08
- 2026-525883-17 (Autre identifiant: EU CT Number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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