Un estudio que evalúa la seguridad y la eficacia de las terapias dirigidas en subpoblaciones de pacientes con cáncer colorrectal metastásico (INTRINSIC)
Un estudio general de fase I/Ib global, multicéntrico y abierto que evalúa la seguridad y la eficacia de las terapias dirigidas en subpoblaciones de pacientes con cáncer colorrectal metastásico (INTRINSIC)
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Copia de seguridad de contactos de estudio
- Nombre: Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below.
- Número de teléfono: 888-662-6728 (U.S. and Canada)
- Correo electrónico: global-roche-genentech-trials@gene.com
Ubicaciones de estudio
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Berlin, Alemania, 13353
- Reclutamiento
- Charité Universitätsmedizin Berlin
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Bochum, Alemania, 44791
- Reclutamiento
- Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
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Dresden, Alemania, 01307
- Reclutamiento
- Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
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Düsseldorf, Alemania, 40225
- Reclutamiento
- Universitätsklinikum Düsseldorf
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Hamburg, Alemania, 22763
- Reclutamiento
- Asklepios Klinik Altona
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Heilbronn, Alemania, 74078
- Reclutamiento
- SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
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München, Alemania, 81377
- Retirado
- Klinikum der Universität München, Campus Großhadern
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Ulm, Alemania, 89081
- Reclutamiento
- Universitätsklinikum Ulm
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Victoria
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Melbourne, Victoria, Australia, 3000
- Reclutamiento
- Peter Maccallum Cancer Centre
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Ontario
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Toronto, Ontario, Canadá, M5G 1X6
- Activo, no reclutando
- Princess Margaret Cancer Center
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
- Retirado
- Jewish General Hospital
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Montreal, Quebec, Canadá, H4A 3J1
- Retirado
- McGill University Health Center
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Goyang-si, Corea del Sur, 10408
- Reclutamiento
- National Cancer Center
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Jeollanam-do, Corea del Sur, 58128
- Reclutamiento
- Chonnam National University Hwasun Hospital
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Seongnam-si, Corea del Sur, 13605
- Reclutamiento
- Seoul National University Bundang Hospital
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Seoul, Corea del Sur, 05505
- Reclutamiento
- Asan Medical Center
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Seoul, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital
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Seoul, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital, Yonsei University Health System
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Seoul, Corea del Sur, (0)6351
- Reclutamiento
- Samsung Medical Center
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Herlev, Dinamarca, 2730
- Reclutamiento
- Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed
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København Ø, Dinamarca, 2100
- Terminado
- Rigshospitalet, Onkologisk Klinik
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Barcelona, España, 08035
- Reclutamiento
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Madrid, España, 28050
- Retirado
- START Madrid. Centro Integral Oncologico Clara Campal
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Madrid, España, 28040
- Reclutamiento
- START Madrid-FJD, Hospital Fundacion Jimenez Diaz
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Valencia, España, 46010
- Reclutamiento
- Hospital Clínico Universitario de Valencia
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Zaragoza, España, 50009
- Reclutamiento
- Hospital Clinico Universitario Lozano Blesa
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Guipuzcoa
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Donostia / San Sebastian, Guipuzcoa, España, 20080
- Reclutamiento
- Hospital Universitario de Donostia
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Madrid
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Majadahonda, Madrid, España, 28222
- Reclutamiento
- Hospital Universitario Puerta de Hierro - Majadahonda
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Retirado
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85259
- Activo, no reclutando
- Mayo Clinic Arizona
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California
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Duarte, California, Estados Unidos, 91010
- Reclutamiento
- City of Hope Comprehensive Cancer Center
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Encinitas, California, Estados Unidos, 92024
- Retirado
- cCare
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Los Angeles, California, Estados Unidos, 90048
- Reclutamiento
- Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90095
- Reclutamiento
- UCLA
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Los Angeles, California, Estados Unidos, 90033
- Terminado
- USC Norris Cancer Center
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Newport Beach, California, Estados Unidos, 92663
- Retirado
- Hoag Memorial Hospital Presbyterian
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Stanford, California, Estados Unidos, 94305-5820
- Terminado
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- University of Colorado Cancer Center
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Lone Tree, Colorado, Estados Unidos, 80124
- Reclutamiento
- Rocky Mountain Cancer Centers, LLP
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Reclutamiento
- Yale Cancer Center
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Norwich, Connecticut, Estados Unidos, 06360
- Retirado
- Eastern Ct Hema/Onco Assoc
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Terminado
- Mayo Clinic in Florida
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Tampa, Florida, Estados Unidos, 33612
- Reclutamiento
- Moffitt Cancer Center
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Illinois
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Arlington Heights, Illinois, Estados Unidos, 60005
- Reclutamiento
- Illinois Cancer Specialists
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Reclutamiento
- Mary Bird Perkins Cancer Ctr
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114-2621
- Terminado
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Retirado
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55902
- Reclutamiento
- Mayo Clinic Rochester
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New York
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New Hyde Park, New York, Estados Unidos, 11042-1116
- Reclutamiento
- New York Cancer & Blood Specialists - New Hyde Park
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New York, New York, Estados Unidos, 10028
- Reclutamiento
- New York Cancer and Blood Specialists-Central Park Hematology & Oncology
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Port Jefferson Station, New York, Estados Unidos, 11776
- Reclutamiento
- New York Cancer & Blood Specialists
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The Bronx, New York, Estados Unidos, 10469-5930
- Reclutamiento
- New York Cancer & Blood Specialists - Bronx
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Terminado
- Duke University Medical Center
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Oregon
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Salem, Oregon, Estados Unidos, 97301
- Terminado
- Hematology Oncology Salem
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- Activo, no reclutando
- UPMC - Hillman Cancer Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Terminado
- Vanderbilt University Medical Center
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- SCRI Oncology Partners
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Nashville, Tennessee, Estados Unidos, 37203
- Terminado
- Sarah Cannon Research Institute / Tennessee Oncology
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Texas
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Denton, Texas, Estados Unidos, 76201
- Reclutamiento
- Texas Oncology - Northeast Texas
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Kingwood, Texas, Estados Unidos, 77339
- Retirado
- Lumi Research
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Webster, Texas, Estados Unidos, 77598-4420
- Reclutamiento
- Texas Oncology - Gulf Coast
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Terminado
- Swedish Cancer Inst.
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Spokane, Washington, Estados Unidos, 99208
- Retirado
- Medical Oncology Associates
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Campania
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Naples, Campania, Italia, 80131
- Reclutamiento
- Università degli Studi della Campania Luigi Vanvitelli
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italia, 47014
- Reclutamiento
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
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Lazio
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Rome, Lazio, Italia, 00168
- Reclutamiento
- Policlinico Universitario Agostino Gemelli IRCCS
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Lombardy
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Milan, Lombardy, Italia, 20162
- Reclutamiento
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Milan, Lombardy, Italia, 20133
- Retirado
- Irccs Istituto Nazionale Dei Tumori (Int)
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Veneto
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Padova, Veneto, Italia, 35128
- Reclutamiento
- IRCCS Istituto Oncologico Veneto (IOV)
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Gdansk, Polonia, 80-952
- Reclutamiento
- Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
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Krakow, Polonia, 30-688
- Suspendido
- Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
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Poznan, Polonia, 60-569
- Reclutamiento
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warsaw, Polonia, 02-781
- Suspendido
- Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
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Cambridge, Reino Unido, CB2 0QQ
- Reclutamiento
- Addenbrookes Hospital
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Cardiff, Reino Unido, CF14 2TL
- Reclutamiento
- Velindre Cancer Centre
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London, Reino Unido, W2 1NY
- Reclutamiento
- Imperial College Healthcare NHS Trust
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London, Reino Unido, W1G 6AD
- Reclutamiento
- Sarah Cannon Research Institute
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London, Reino Unido, NW3 2QG
- Retirado
- Royal Free Hospital
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London, Reino Unido, SW3 6JJ
- Reclutamiento
- Royal Marsden Hospital;Dept of Med-Onc
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Manchester, Reino Unido, M20 4BX
- Reclutamiento
- The Christie NHS Foundation Trust
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Sutton, Reino Unido, SM2 5PT
- Reclutamiento
- Royal Marsden Hospital
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Tainan, Taiwán, 00704
- Reclutamiento
- National Cheng Kung University Hospital
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Taipei, Taiwán, 112201
- Reclutamiento
- Taipei Veterans General Hospital
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Zhongzheng Dist., Taiwán, 10048
- Reclutamiento
- National Taiwan University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
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Signed cohort-specific Informed Consent Form
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Age >= 18 years at time of signing Informed Consent Form
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Biomarker eligibility as determined by:
- A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
- A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.
- Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR
- Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.
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Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
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Life expectancy >= 3 months, as determined by the investigator
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Histologically confirmed adenocarcinoma originating from the colon or rectum
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Metastatic disease
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Prior therapies for metastatic disease
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Ability to comply with the study protocol, in the investigators judgment
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Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
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Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research
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Adequate hematologic and organ function within 14 days prior to initiation of study treatment
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For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
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For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria
- Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.
- Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Pregnant or breastfeeding, or intending to become pregnant during the study
- History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia
- Clinically significant and active liver disease
- Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
- Symptomatic, untreated, or actively progressing CNS metastases
- History of leptomeningeal disease or carcinomatous meningitis
- History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
- Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications
Plan de estudios
¿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: Inavolisib + Cetuximab
Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days). Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each. This arm is closed. |
Inavolisib will be administered orally as per schedule specified in the respective arms. Cetuximab IV will be administered as per schedule specified in the respective arm. FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. |
|
Experimental: Inavolisib + Bevacizumab
Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days). This arm is closed. |
Inavolisib will be administered orally as per schedule specified in the respective arms. FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Bevacizumab IV will be administered as per schedule specified in the respective arm.
Otros nombres:
|
|
Experimental: Atezolizumab + Tiragolumab + Bevacizumab
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants. |
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Bevacizumab IV will be administered as per schedule specified in the respective arm.
Otros nombres:
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Otros nombres:
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm. |
|
Experimental: Atezolizumab + Tiragolumab
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants. |
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Otros nombres:
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm. |
|
Experimental: Atezolizumab + SY-5609
Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) This arm is closed. |
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Otros nombres:
SY-5609 will be administered by mouth as per schedule specified in the respective arm. |
|
Experimental: Divarasib + Cetuximab + FOLFOX
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants. |
Cetuximab IV will be administered as per schedule specified in the respective arm. FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Divarasib will be administered orally as per schedule specified in the respective arms.
Otros nombres:
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm. |
|
Experimental: Divarasib + Cetuximab
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants. |
Cetuximab IV will be administered as per schedule specified in the respective arm. FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Divarasib will be administered orally as per schedule specified in the respective arms.
Otros nombres:
|
|
Experimental: Divarasib + Cetuximab + FOLFIRI
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants. |
Cetuximab IV will be administered as per schedule specified in the respective arm. FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Divarasib will be administered orally as per schedule specified in the respective arms.
Otros nombres:
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm. |
|
Experimental: Divarasib + Bevacizumab + FOLFOX
Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFOX on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants. |
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Bevacizumab IV will be administered as per schedule specified in the respective arm.
Otros nombres:
Divarasib will be administered orally as per schedule specified in the respective arms.
Otros nombres:
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm. |
|
Experimental: Divarasib + Bevacizumab + FOLFIRI
Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFIRI on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants. |
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment. Bevacizumab IV will be administered as per schedule specified in the respective arm.
Otros nombres:
Divarasib will be administered orally as per schedule specified in the respective arms.
Otros nombres:
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response Rate
Periodo de tiempo: Approximately 84 months
|
Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1 |
Approximately 84 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Duration of Response
Periodo de tiempo: Approximately 84 months
|
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 |
Approximately 84 months
|
|
Disease Control Rate
Periodo de tiempo: Approximately 84 months
|
Defined as the proportion of participants with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1 |
Approximately 84 months
|
|
Percentage of Participants with Adverse Events (AEs)
Periodo de tiempo: Approximately 84 months
|
Percentage of participants with adverse events. |
Approximately 84 months
|
|
Plasma Concentrations of Divarasib
Periodo de tiempo: At pre-defined intervals from first administration of study drug up to approximately 84 months
|
Plasma concentration of divarasib for divarasib + cetuximab + FOLFOX, divarasib + cetuximab, and divarasib + cetuximab+ FOLFIRI, Divarasib + Bevacizumab + FOLFOX, Divarasib + Bevacizumab + FOLFIRI treatment arms. |
At pre-defined intervals from first administration of study drug up to approximately 84 months
|
|
Recommended Dose of Divarasib in Combination with Bevacizumab and FOLFOX
Periodo de tiempo: Approximately 84 months
|
Recommended dose of divarasib in combination with bevacizumab and FOLFOX based on the totality of safety, efficacy and PK data. |
Approximately 84 months
|
|
Recommended Dose of Divarasib in Combination with Bevacizumab and FOLFIRI
Periodo de tiempo: Approximately 84 months
|
Recommended dose of divarasib in combination with bevacizumab and FOLFIRI based on the totality of safety, efficacy and PK data. |
Approximately 84 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades del Colon
- Neoplasias colorrectales
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Bevacizumab
- Cetuximab
- atezolizumab
- Tiragolumab
- inavolisib
- Protocolo de Folfox
- Protocolo IFL
- SY-5609
Otros números de identificación del estudio
- WO42758
- 2021-001207-33 (Número EudraCT)
- 2023-505163-37-00 (Otro identificador: CTIS (EU))
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .