New cancer drug sigvotatug vedotin enters human trials
NCT ID NCT04389632
First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This early-stage trial is testing a new drug called sigvotatug vedotin, alone or with other cancer medicines, in people with advanced solid tumors like lung, head and neck, and breast cancers. The study aims to find a safe dose and check for side effects. About 1,000 participants will take part across four parts of the study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sigvotatug vedotin (SGN-B6A)
- What this could lead to
- If it works, this could point toward a new treatment option for several advanced solid tumors that are hard to treat.
- What could go wrong
- This is an early phase 1 trial, so the main goal is safety, not proof of effectiveness. The drug may cause side effects or not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 1,006 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Disease indication * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part). * Non-small cell lung cancer (NSCLC) * Head and neck squamous cell cancer (HNSCC) * Advanced HER2-negative breast cancer * Esophageal squamous cell carcinoma (ESCC) * Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ) * Cutaneous squamous cell cancer (cSCC) * Exocrine pancreatic adenocarcinoma * Bladder cancer * Cervical cancer * Gastric cancer * High grade serous ovarian cancer (HGSOC) * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options. * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available. * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \[neo\]adjuvant therapy is allowed). * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy. * Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows: * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used. * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Measurable disease per the RECIST v1.1 at baseline Exclusion Criteria * History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. * Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they: * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, * have no new or enlarging brain metastases, and * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug. * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids. * Carcinomatous meningitis * Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6 * Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts * Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin. * Routine antimicrobial prophylaxis is permitted * Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses * Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE). * History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening * Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted * Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
155 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alaska Oncology and Hematology
RECRUITINGAnchorage, Alaska, 99508, United States
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Allina Health Cancer Institute
RECRUITINGSaint Paul, Minnesota, 55102, United States
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Allina Health Cancer Institute - Abbott Northwestern Hospital
RECRUITINGMinneapolis, Minnesota, 55407, United States
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Allina Health Cancer Institute - Mercy Hospital
RECRUITINGCoon Rapids, Minnesota, 55433, United States
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Allina Health Cancer Institute - United Hospital
RECRUITINGSaint Paul, Minnesota, 55102, United States
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American Oncology Network Vista Oncology Division-East office
RECRUITINGOlympia, Washington, 98506, United States
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American Oncology Network Vista Oncology Division-West office
RECRUITINGOlympia, Washington, 98502, United States
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American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology
RECRUITINGFort Myers, Florida, 33913, United States
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Area general-Planta Baixa | Unitat d'investigacio en terapia Molecular del Cancer "la Caixa"
RECRUITINGBarcelona, 08035, Spain
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Beth Israel Deaconess Medical Center,East Campus Research Pharmacy
RECRUITINGBoston, Massachusetts, 02215, United States
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Brigham & Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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CHUV - Service de pharmacie BH-04, Essais cliniques
RECRUITINGLausanne, CH-1011, Switzerland
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Cancer AND Blood Specialty Clinic
NOT_YET_RECRUITINGTorrance, California, 90505, United States
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Cancer and Blood Research Center, LLC
NOT_YET_RECRUITINGLos Alamitos, California, 90720, United States
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Cancer and Blood Specialty Clinic
NOT_YET_RECRUITINGLos Alamitos, California, 90720, United States
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Center Hospitalier Universitaire d' Angers
ACTIVE_NOT_RECRUITINGAngers, 49100, France
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Centre Hospitalier Universitaire de Poitiers
RECRUITINGPoitiers, 86021, France
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Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
RECRUITINGNice, 06189, France
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Chungbuk National University Hospital
RECRUITINGCheongju-si, North Chungcheong, 28644, South Korea
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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Community Health Network Investigational Drug Services
RECRUITINGIndianapolis, Indiana, 46250, United States
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Community Health Network, Inc
RECRUITINGIndianapolis, Indiana, 46219, United States
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Community Health Network, Inc.
RECRUITINGIndianapolis, Indiana, 46227, United States
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Community Health Network, Inc.
RECRUITINGIndianapolis, Indiana, 46250, United States
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Comprehensive Cancer Centers of Nevada
RECRUITINGLas Vegas, Nevada, 89169, United States
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Dana-Farber Cancer Institute - Chestnut Hill
RECRUITINGNewton, Massachusetts, 02467, United States
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Diagnostic centre
RECRUITINGLondon, W1G 7AF, United Kingdom
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Elche General University Hospital
RECRUITINGElche, Alicante, 03203, Spain
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Elche General University Hospital
RECRUITINGElche, Valencia, 03203, Spain
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Elche General University Hospital
RECRUITINGElche, 03203, Spain
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Equipo de Farmacia Oncológica- Ensayos Clínicos Servicio de Farmacia Hospital Universitario Marqués
RECRUITINGSantander, Cantabria, 39008, Spain
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Exigent Research, LLC
RECRUITINGTacoma, Washington, 98405, United States
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Farmacia Ensayos Hospital HM Universitario Sanchinarro
RECRUITINGMadrid, Agrigento, 28050, Spain
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Farmacia Ensayos clínicos, Unidad START Barcelona
RECRUITINGBarcelona, 08023, Spain
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Florida Cancer Specialists
RECRUITINGOrlando, Florida, 32827, United States
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Florida Cancer Specialists & Research Institute, LLC
RECRUITINGFort Myers, Florida, 33916, United States
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Fort Wayne Medical Oncology and Hematology, Inc
RECRUITINGFort Wayne, Indiana, 46804, United States
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Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
RECRUITINGBarcelona, Other, 08035, Spain
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Fundación de Investigación Hm Hospitales, C.I.F. G-83643841
RECRUITINGMadrid, 28015, Spain
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Highlands Oncology Group
RECRUITINGFayetteville, Arkansas, 72703, United States
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Highlands Oncology Group
RECRUITINGRogers, Arkansas, 72758, United States
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Highlands Oncology Group
RECRUITINGSpringdale, Arkansas, 72762, United States
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Hospital General Universitario de Elche
RECRUITINGElche, Valencia, 03203, Spain
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Hospital HM Nou Delfos
RECRUITINGBarcelona, Catalonia, 08023, Spain
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Hospital HM Nou Delfos - START Barcelona
RECRUITINGBarcelona, 08023, Spain
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Hospital HM Sanchinarro, START-Madrid-CIOCC
RECRUITINGMadrid, 28050, Spain
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Hospital Quiron Salud Barcelona
RECRUITINGBarcelona, 08023, Spain
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Hospital Universitario 12 Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario De Jerez
RECRUITINGJerez de la Frontera, 10407, Spain
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Hospital Universitario Marques de Valdecilla
RECRUITINGSantander, Cantabria, 39008, Spain
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Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Universitario de Jerez
RECRUITINGJerez de la Frontera, 11407, Spain
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Hospital Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Houston Medical Imaging
NOT_YET_RECRUITINGPearland, Texas, 77581, United States
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Ingalls Family Care Center
RECRUITINGCalumet City, Illinois, 60409, United States
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Institut Gustave Roussy Department de Pharmacie Clinique(-1)
RECRUITINGVillejuif, 94805., France
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Institut de Cancérologie de Lorraine
RECRUITINGVandœuvre-lès-Nancy, 54519, France
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Kantonsspital Graubunden
RECRUITINGChur, 7000, Switzerland
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Kaohsiung Medical University Hospital
RECRUITINGKaohsiung City, R.o.c., 80756, Taiwan
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Korea University Guro Hospital
RECRUITINGSeoul, 08308, South Korea
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Memorial Cancer Institute
RECRUITINGHollywood, Florida, 33021, United States
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Memorial Cancer Institute at Memorial Hospital West
RECRUITINGPembroke Pines, Florida, 33028, United States
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Memorial Healthcare System
RECRUITINGHollywood, Florida, 33021, United States
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Memorial Hospital West
RECRUITINGPembroke Pines, Florida, 33028, United States
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NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
RECRUITINGBarcelona, OTH, 08023, Spain
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National Cancer Center
RECRUITINGGoyang-si, Gyeonggi-do, 10408, South Korea
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National Taiwan University Hospital
RECRUITINGTaipei, 100, R.O.C, Taiwan
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGBabylon, New York, 11702, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGBrooklyn, New York, 11210, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGNew Hyde Park, New York, 11042, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGNew York, New York, 10028, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGPatchogue, New York, 11772, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGPort Jefferson Station, New York, 11776, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGRiverhead, New York, 11901, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGShirley, New York, 11967, United States
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North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITINGThe Bronx, New York, 10469, United States
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Northwest Medical Specialities, PLLC
NOT_YET_RECRUITINGTacoma, Washington, 98405, United States
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Northwest Medical Specialities. PLLC
NOT_YET_RECRUITINGBonney Lake, Washington, 98391, United States
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Northwest Medical Specialities. PLLC
NOT_YET_RECRUITINGGig Harbor, Washington, 98332, United States
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Northwest Medical Specialities.PLLC
NOT_YET_RECRUITINGFederal Way, Washington, 98003, United States
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Northwest Medical Specialties, PPLC
NOT_YET_RECRUITINGPuyallup, Washington, 98373, United States
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OU Health University of Oklahoma Medical Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Oncology Consultants, PA
RECRUITINGHouston, Texas, 77024, United States
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Oncology Consultants, PA.
RECRUITINGHouston, Texas, 77030, United States
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Providence Cancer Institute Franz Clinic
RECRUITINGPortland, Oregon, 97213, United States
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Providence Medical Foundation
RECRUITINGAnaheim, California, 92805, United States
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Providence Medical Foundation
RECRUITINGFullerton, California, 92835, United States
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Providence Oncology and Hematology Care Clinic - Westside
RECRUITINGPortland, Oregon, 97225, United States
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Providence St. Jude Medical Center Virginia K Crosson and Infusion Center
RECRUITINGFullerton, California, 92835, United States
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Providence St. Vincent Medical Center
RECRUITINGPortland, Oregon, 97225, United States
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Providence St. Vincent Medical Center- Investigational Drug Services
RECRUITINGPortland, Oregon, 97225, United States
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Queen Elizabeth Hospital
RECRUITINGBirmingham, B15 2TH, United Kingdom
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Quironsalud Malaga
RECRUITINGMálaga, 129004, Spain
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Radiology
RECRUITINGLondon, W1G 8PP, United Kingdom
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Ronald Reagan UCLA Medical Center
RECRUITINGLos Angeles, California, 90095, United States
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Royal Marsden Hospital
RECRUITINGSutton, Surrey, SM2 5PT, United Kingdom
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Sanford Cancer Center
RECRUITINGSioux Falls, South Dakota, 57104, United States
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Sanford USD Medical Center
RECRUITINGSioux Falls, South Dakota, 57105, United States
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Sarah Cannon Research Institute
RECRUITINGLondon, W1G 6AD, United Kingdom
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Seoul Metropolitan Government Seoul National University Boramae Medical Center
RECRUITINGSeoul, 07061, South Korea
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Servicio de Radiologia Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, 28034, Spain
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Severance Hospital Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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South Texas Accelerated Research Therapeutics, LLC
ACTIVE_NOT_RECRUITINGSan Antonio, Texas, 78229, United States
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Southern Illinois University - Simmons Cancer Institute
RECRUITINGSpringfield, Illinois, 62702, United States
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Springfield Clinic
RECRUITINGSpringfield, Illinois, 62702, United States
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Springfield Clinic Main Campus
RECRUITINGSpringfield, Illinois, 62703, United States
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Springfield Clinic Radiology - 800 Building
RECRUITINGSpringfield, Illinois, 62702, United States
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Springfield Clinic Radiology - Main Campus
RECRUITINGSpringfield, Illinois, 62703, United States
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Springfield Clinic Urgent Care Plus
RECRUITINGSpringfield, Illinois, 62702, United States
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Springfield Memorial Hospital
RECRUITINGSpringfield, Illinois, 62781, United States
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Stephenson Cancer Center (chemo location)
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Swedish Cancer Institute
RECRUITINGSeattle, Washington, 98104, United States
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Swedish Cancer Institute - Edmonds Campus
RECRUITINGEdmonds, Washington, 98026, United States
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Swedish Cancer Institute Edmonds Campus
RECRUITINGEdmonds, Washington, 98026, United States
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Swedish Medical Center
RECRUITINGSeattle, Washington, 98122, United States
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Taipei Veterans General Hospital.
RECRUITINGTaipei, 11217, Taiwan
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The Catholic University of Korea
RECRUITINGSeoul, 06591, South Korea
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The Harley Street Clinic
RECRUITINGLondon, W1G 8BJ, United Kingdom
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The Regents of the University of California
RECRUITINGLos Angeles, California, 90095, United States
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The Royal Marsden Hospital (Surrey)
RECRUITINGSutton, Queensland, SM2 5PT, United Kingdom
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The Royal Marsden NHS Foundation Trust
RECRUITINGLondon, SW3 6JJ, United Kingdom
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The University Of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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The University of Chicago Medicine Center for Advanced Care Orland Park
RECRUITINGOrland Park, Illinois, 60462, United States
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The University of Kansas Cancer Center - Indian Creek Campus
RECRUITINGOverland Park, Kansas, 66211, United States
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The University of Kansas Cancer Center - Westwood
RECRUITINGWestwood, Kansas, 66205, United States
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The University of Kansas Cancer Center, Investigational Drug Services
RECRUITINGFairway, Kansas, 66205, United States
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The University of Kansas Clinical Research Center
RECRUITINGFairway, Kansas, 66205, United States
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The University of Kansas Hospital
RECRUITINGKansas City, Kansas, 66160, United States
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The University of Kansas Medical Center Medical Office Building
RECRUITINGKansas City, Kansas, 66160, United States
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The University of Texas M.D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Tranquil Clinical Research
NOT_YET_RECRUITINGWebster, Texas, 77598, United States
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UCLA Department of Medicine - Hematology & Oncology
RECRUITINGSanta Monica, California, 90404, United States
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UCLA Department of Medicine-Hematology/Oncology
RECRUITINGLos Angeles, California, 90095, United States
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UChicago Medicine - Northwest Indiana
RECRUITINGCrown Point, Indiana, 46307, United States
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UChicago Medicine - River East
RECRUITINGChicago, Illinois, 60611, United States
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UChicago Medicine Ingalls Memorial
RECRUITINGHarvey, Illinois, 60426, United States
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UChicago Medicine at Ingalls - Flossmoor
RECRUITINGFlossmoor, Illinois, 60422, United States
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UChicago Medicine at Ingalls - Tinley Park
RECRUITINGTinley Park, Illinois, 60477, United States
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UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez
RECRUITINGJerez de la Frontera, 10407, Spain
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US Oncology Investigational Product Center (IPC)
RECRUITINGIrving, Texas, 75063, United States
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US Oncology Research LLC
RECRUITINGNashville, Tennessee, 37203, United States
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UT Health East Texas HOPE Cancer Center
RECRUITINGTyler, Texas, 75701, United States
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UT Health East Texas Hope Cancer Center
RECRUITINGTyler, Texas, 75708, United States
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University Hospital Lausanne CHUV
RECRUITINGLausanne, 1011, Switzerland
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University Hospitals Birmingham NHS Foundation Trust
RECRUITINGBirmingham, B15 2TH, United Kingdom
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University Hospitals Cleveland Medical Center
ACTIVE_NOT_RECRUITINGCleveland, Ohio, 44106, United States
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University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
RECRUITINGNew Lenox, Illinois, 60451, United States
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University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
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University of Kansas Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of Kansas Hospital Cambridge North Tower A
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Medical Center Research Institute
RECRUITINGKansas City, Kansas, 66160, United States
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University of Oklahoma Health Science Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Virginia Cancer Specialists
RECRUITINGFairfax, Virginia, 22031, United States
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lnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)
RECRUITINGVillejuif, 94805., France
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