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 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
960
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Genmab Trial Information
- Número de teléfono: +4570202728
- Correo electrónico: clinicaltrials@genmab.com
Ubicaciones de estudio
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Georgia
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Savannah, Georgia, Estados Unidos, 31405
- Reclutamiento
- Low Country Cancer Care Associates_Savannah_1
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Warner Robins, Georgia, Estados Unidos, 31088
- Reclutamiento
- Central Georgia Cancer Care - Warner Robins Office
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- Reclutamiento
- Hematology-Oncology of Indiana, P.C.
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Missouri
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Springfield, Missouri, Estados Unidos, 65807
- Reclutamiento
- Oncology Hematology Associates - Springfield_Springfield_2
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Washington
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Olympia, Washington, Estados Unidos, 98502
- Reclutamiento
- Vista Oncology
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PR
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Manati, PR, Puerto Rico, 00674
- Reclutamiento
- PanOncology
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: Cetuximab + IC Chemotherapy
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
|
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Intravenous infusion
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Periodo de tiempo: Up to approximately 35 months
|
Up to approximately 35 months
|
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Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
Periodo de tiempo: Up to approximately 35 months
|
Up to approximately 35 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Overall Survival (OS)
Periodo de tiempo: 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
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Progression-free Survival after First Subsequent Therapy (PFS2)
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Curative Resection (R0) Rate
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Number of Participants with Adverse Events (AEs)
Periodo de tiempo: 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
Periodo de tiempo: Baseline up to approximately 62 months
|
Baseline up to approximately 62 months
|
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Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Periodo de tiempo: 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
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Overall Side Effect Burden, as Measured by EORTC Item 168
Periodo de tiempo: Up to approximately 62 months
|
Up to approximately 62 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Study Official, Genmab
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de agosto de 2026
Finalización primaria (Estimado)
1 de julio de 2029
Finalización del estudio (Estimado)
1 de septiembre de 2031
Fechas de registro del estudio
Enviado por primera vez
9 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GCT1158-08
- 2026-525883-17 (Otro identificador: EU CT Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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