En studie som evaluerer sikkerheten og effekten av målrettede terapier i underpopulasjoner av pasienter med metastatisk tykktarmskreft (INTRINSIC)
En fase I/Ib global, multisenter, åpen paraplystudie som evaluerer sikkerheten og effekten av målrettede terapier i underpopulasjoner av pasienter med metastatisk tykktarmskreft (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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-post: global-roche-genentech-trials@gene.com
Studiesteder
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Victoria
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Melbourne, Victoria, Australia, 3000
- Rekruttering
- Peter Maccallum Cancer Centre
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Ontario
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Toronto, Ontario, Canada, M5G 1X6
- Aktiv, ikke rekrutterende
- Princess Margaret Cancer Center
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Tilbaketrukket
- Jewish General Hospital
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Montreal, Quebec, Canada, H4A 3J1
- Tilbaketrukket
- McGill University Health Center
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Herlev, Danmark, 2730
- Rekruttering
- Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed
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København Ø, Danmark, 2100
- Fullført
- Rigshospitalet, Onkologisk Klinik
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Tilbaketrukket
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Forente stater, 85259
- Aktiv, ikke rekrutterende
- Mayo Clinic Arizona
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California
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope Comprehensive Cancer Center
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Encinitas, California, Forente stater, 92024
- Tilbaketrukket
- cCare
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Los Angeles, California, Forente stater, 90048
- Rekruttering
- Cedars-Sinai Medical Center
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Los Angeles, California, Forente stater, 90095
- Rekruttering
- UCLA
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Los Angeles, California, Forente stater, 90033
- Fullført
- USC Norris Cancer Center
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Newport Beach, California, Forente stater, 92663
- Tilbaketrukket
- Hoag Memorial Hospital Presbyterian
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Stanford, California, Forente stater, 94305-5820
- Fullført
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Cancer Center
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Lone Tree, Colorado, Forente stater, 80124
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Connecticut
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New Haven, Connecticut, Forente stater, 06520
- Rekruttering
- Yale Cancer Center
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Norwich, Connecticut, Forente stater, 06360
- Tilbaketrukket
- Eastern Ct Hema/Onco Assoc
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Fullført
- Mayo Clinic in Florida
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffitt Cancer Center
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Illinois
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Arlington Heights, Illinois, Forente stater, 60005
- Rekruttering
- Illinois Cancer Specialists
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Rekruttering
- Mary Bird Perkins Cancer Ctr
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114-2621
- Fullført
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Tilbaketrukket
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Forente stater, 55902
- Rekruttering
- Mayo Clinic Rochester
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New York
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New Hyde Park, New York, Forente stater, 11042-1116
- Rekruttering
- New York Cancer & Blood Specialists - New Hyde Park
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New York, New York, Forente stater, 10028
- Rekruttering
- New York Cancer and Blood Specialists-Central Park Hematology & Oncology
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Port Jefferson Station, New York, Forente stater, 11776
- Rekruttering
- New York Cancer & Blood Specialists
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The Bronx, New York, Forente stater, 10469-5930
- Rekruttering
- New York Cancer & Blood Specialists - Bronx
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Fullført
- Duke University Medical Center
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Oregon
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Salem, Oregon, Forente stater, 97301
- Fullført
- Hematology Oncology Salem
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- Aktiv, ikke rekrutterende
- UPMC - Hillman Cancer Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Fullført
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Nashville, Tennessee, Forente stater, 37203
- Fullført
- Sarah Cannon Research Institute / Tennessee Oncology
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Texas
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Denton, Texas, Forente stater, 76201
- Rekruttering
- Texas Oncology - Northeast Texas
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Kingwood, Texas, Forente stater, 77339
- Tilbaketrukket
- Lumi Research
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Webster, Texas, Forente stater, 77598-4420
- Rekruttering
- Texas Oncology - Gulf Coast
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Washington
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Seattle, Washington, Forente stater, 98104
- Fullført
- Swedish Cancer Inst.
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Spokane, Washington, Forente stater, 99208
- Tilbaketrukket
- Medical Oncology Associates
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Campania
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Naples, Campania, Italia, 80131
- Rekruttering
- Università degli Studi della Campania Luigi Vanvitelli
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italia, 47014
- Rekruttering
- 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
- Rekruttering
- Policlinico Universitario Agostino Gemelli IRCCS
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Lombardy
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Milan, Lombardy, Italia, 20162
- Rekruttering
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Milan, Lombardy, Italia, 20133
- Tilbaketrukket
- Irccs Istituto Nazionale Dei Tumori (Int)
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Veneto
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Padova, Veneto, Italia, 35128
- Rekruttering
- IRCCS Istituto Oncologico Veneto (IOV)
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Gdansk, Polen, 80-952
- Rekruttering
- Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
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Krakow, Polen, 30-688
- Suspendert
- Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
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Poznan, Polen, 60-569
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warsaw, Polen, 02-781
- Suspendert
- Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
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Barcelona, Spania, 08035
- Rekruttering
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Madrid, Spania, 28050
- Tilbaketrukket
- START Madrid. Centro Integral Oncologico Clara Campal
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Madrid, Spania, 28040
- Rekruttering
- START Madrid-FJD, Hospital Fundacion Jimenez Diaz
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Valencia, Spania, 46010
- Rekruttering
- Hospital Clínico Universitario de Valencia
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Zaragoza, Spania, 50009
- Rekruttering
- Hospital Clinico Universitario Lozano Blesa
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Guipuzcoa
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Donostia / San Sebastian, Guipuzcoa, Spania, 20080
- Rekruttering
- Hospital Universitario de Donostia
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Madrid
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Majadahonda, Madrid, Spania, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro - Majadahonda
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Cambridge, Storbritannia, CB2 0QQ
- Rekruttering
- Addenbrookes Hospital
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Cardiff, Storbritannia, CF14 2TL
- Rekruttering
- Velindre Cancer Centre
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London, Storbritannia, W2 1NY
- Rekruttering
- Imperial College Healthcare NHS Trust
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London, Storbritannia, W1G 6AD
- Rekruttering
- Sarah Cannon Research Institute
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London, Storbritannia, NW3 2QG
- Tilbaketrukket
- Royal Free Hospital
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London, Storbritannia, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital;Dept of Med-Onc
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Manchester, Storbritannia, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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Sutton, Storbritannia, SM2 5PT
- Rekruttering
- Royal Marsden Hospital
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Goyang-si, Sør -Korea, 10408
- Rekruttering
- National Cancer Center
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Jeollanam-do, Sør -Korea, 58128
- Rekruttering
- Chonnam National University Hwasun Hospital
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Seongnam-si, Sør -Korea, 13605
- Rekruttering
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital
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Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
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Seoul, Sør -Korea, (0)6351
- Rekruttering
- Samsung Medical Center
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Tainan, Taiwan, 00704
- Rekruttering
- National Cheng Kung University Hospital
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Taipei, Taiwan, 112201
- Rekruttering
- Taipei Veterans General Hospital
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Zhongzheng Dist., Taiwan, 10048
- Rekruttering
- National Taiwan University Hospital
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Berlin, Tyskland, 13353
- Rekruttering
- Charité Universitätsmedizin Berlin
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Bochum, Tyskland, 44791
- Rekruttering
- Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
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Dresden, Tyskland, 01307
- Rekruttering
- Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
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Düsseldorf, Tyskland, 40225
- Rekruttering
- Universitätsklinikum Düsseldorf
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Hamburg, Tyskland, 22763
- Rekruttering
- Asklepios Klinik Altona
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Heilbronn, Tyskland, 74078
- Rekruttering
- SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
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München, Tyskland, 81377
- Tilbaketrukket
- Klinikum der Universität München, Campus Großhadern
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Ulm, Tyskland, 89081
- Rekruttering
- Universitätsklinikum Ulm
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Eksperimentell: 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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Andre navn:
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm. |
|
Eksperimentell: 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.
Andre navn:
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm. |
|
Eksperimentell: 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.
Andre navn:
SY-5609 will be administered by mouth as per schedule specified in the respective arm. |
|
Eksperimentell: 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.
Andre navn:
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm. |
|
Eksperimentell: 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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm. |
|
Eksperimentell: 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.
Andre navn:
Divarasib will be administered orally as per schedule specified in the respective arms.
Andre navn:
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm. |
|
Eksperimentell: 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.
Andre navn:
Divarasib will be administered orally as per schedule specified in the respective arms.
Andre navn:
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Response
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Approximately 84 months
|
Percentage of participants with adverse events. |
Approximately 84 months
|
|
Plasma Concentrations of Divarasib
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolonsykdommer
- Kolorektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Bevacizumab
- Cetuximab
- Atezolizumab
- Tiragolumab
- Inavolisib
- FOLFOX -protokoll
- IFL -protokoll
- SY-5609
Andre studie-ID-numre
- WO42758
- 2021-001207-33 (EudraCT-nummer)
- 2023-505163-37-00 (Annen identifikator: CTIS (EU))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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