Norman Golchert 13125 Berlin (Berlin) GermanyZurückgezogen» Google-MapsJeanette Natschke 13359 Berlin (Berlin) GermanyZurückgezogen» Google-MapsThea Resch 45136 Essen (Nordrhein-Westfalen) GermanyZurückgezogen» Google-Maps
Asklepios Clinical Center Harburg 21075 Hamburg (Hamburg) GermanyZurückgezogen» Google-MapsUniversity of Arizona Cancer Center 85724 Tucson United StatesAbgeschlossen» Google-MapsCity of Hope - Duarte 91010 Duarte United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of California, San Diego (UCSD) - Moores Cancer Center 92093 La Jolla United StatesAktiv, nicht rekrutierend» Google-MapsCalifornia Research Institute 90027 Los Angeles United StatesAktiv, nicht rekrutierend» Google-MapsUSC Norris 90033 Los Angeles United StatesAktiv, nicht rekrutierend» Google-MapsUC Irvine Medical Center - Chao Family Comprehensive Cancer Center 92868 Orange United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of California San Francisco 94158 San Francisco United StatesAktiv, nicht rekrutierend» Google-MapsAmerican Institute of Research 90603 Whittier United StatesAbgeschlossen» Google-MapsUniversity of Colorado 80045 Aurora United StatesRekrutierend» Google-Maps Ansprechpartner: Teresa Medina, MD Phone: 303-266-3764 E-Mail: theresa.medina@ucdenver.edu
Rebeca Elizondo Phone: 720-848-4288 E-Mail: rebeca.elizondo@cuanschutz.edu» Ansprechpartner anzeigenSarah Cannon Research Institute at Health One 80218 Denver United StatesRekrutierend» Google-Maps Ansprechpartner: Gerald Falchook, MD Phone: 720-754-2610 E-Mail: gerald.falchook@scresaerch.net
Susan Hall Phone: 720-754-2610 E-Mail: Susan.Hall3@sarahcannon.com» Ansprechpartner anzeigenFlorida Cancer Specialists & Research Institute 32003 Fleming Island United StatesAktiv, nicht rekrutierend» Google-MapsFlorida Cancer Specialists & Research Institute 33916 Fort Myers United StatesRekrutierend» Google-Maps Ansprechpartner: Donna-May Bernard Phone: 239-274-9930 E-Mail: Donna.Bernard@flcancer.com» Ansprechpartner anzeigenMemorial Cancer Institute (MCI) 33028 Hollywood United StatesAbgeschlossen» Google-MapsFlorida Cancer Specialist - North 34474 Saint Petersburg United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan-Kettering Cancer Center 33612 Tampa United StatesAktiv, nicht rekrutierend» Google-MapsMoffitt Cancer Center 33612 Tampa United StatesAktiv, nicht rekrutierend» Google-MapsFlorida Cancer Specialists 33401 West Palm Beach United StatesAktiv, nicht rekrutierend» Google-MapsAugusta University - Georgia Cancer Center 30912 Augusta United StatesAbgeschlossen» Google-MapsBaptist Health Systems 40503 Lexington United StatesAbgeschlossen» Google-MapsUniversity of Kentucky 40536 Lexington United StatesAbgeschlossen» Google-MapsNorton Cancer Institute, Brownsboro Hospital Campus 40241 Louisville United StatesRekrutierend» Google-Maps Ansprechpartner: Pamela Adkisson E-Mail: Pamela.Adkisson@nortonhealthcare.org» Ansprechpartner anzeigenHematology/Oncology Clinic 70809 Baton Rouge United StatesRekrutierend» Google-Maps Ansprechpartner: Aimee Alumbaugh Phone: 225-761-3951 E-Mail: aimee.alumbaugh@aoncology.com» Ansprechpartner anzeigenDana-Farber Cancer Institute 02215 Boston United StatesAbgeschlossen» Google-MapsComprehensive Cancer Care of Nevada 89169 Las Vegas United StatesAbgeschlossen» Google-MapsOptumCare Cancer Care 89169 Las Vegas United StatesAbgeschlossen» Google-MapsRoswell Park 14263 Buffalo United StatesRekrutierend» Google-Maps Ansprechpartner: Julianne Hergenroder Phone: 800-767-9355 E-Mail: askroswell@roswellpark.org» Ansprechpartner anzeigenNYU Langone Health 10016 New York United StatesAktiv, nicht rekrutierend» Google-MapsColumbia University Medical Center 10032 New York United StatesAktiv, nicht rekrutierend» Google-MapsFirstHealth Outpatient Cancer Center 28374 Pinehurst United StatesAktiv, nicht rekrutierend» Google-MapsWake Forest Baptist Health 27157 Winston-Salem United StatesAbgeschlossen» Google-MapsThe Christ Hospital 45219 Cincinnati United StatesAktiv, nicht rekrutierend» Google-MapsOregon Health & Science University 97239 Portland United StatesAbgeschlossen» Google-MapsUPMC Cancer Center 15232 Pittsburgh United StatesRekrutierend» Google-Maps Ansprechpartner: Deb Mayr Phone: 412-623-4029 E-Mail: mayrdc@upmc.edu» Ansprechpartner anzeigenMedical University of South Carolina- Hollings Cancer Center 29407 Charleston United StatesAktiv, nicht rekrutierend» Google-MapsSarah Cannon Research Institute 37203 Nashville United StatesRekrutierend» Google-Maps Ansprechpartner: Howard Burris, MD E-Mail: Howard.Burris@SarahCannon.com
Leigh Bumpous Phone: 615-748-0767 E-Mail: Leigh.Bumpous@SarahCannon.com» Ansprechpartner anzeigenMary Crowley Cancer Research 75230 Dallas United StatesAktiv, nicht rekrutierend» Google-MapsMD Anderson Cancer Center 77030 Houston United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Utah - Huntsman Cancer Institute 84112 Salt Lake City United StatesRekrutierend» Google-Maps Ansprechpartner: Mia Klonsky Phone: 801-581-5260 E-Mail: Mia.Klonsky@hci.utah.edu
Ashley Lewary E-Mail: Ashley.Leary@hci.utah.edu» Ansprechpartner anzeigenHENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit 11526 Athens GreeceAbgeschlossen» Google-Maps"Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit 11527 Athens GreeceZurückgezogen» Google-MapsMetropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department 18547 Piraeus GreeceAbgeschlossen» Google-MapsBioclinic Thessaloniki, Οncology Department 54622 Thessaloniki GreeceRekrutierend» Google-Maps Ansprechpartner: Panagiota Papadopoulou E-Mail: giota0806@gmail.com» Ansprechpartner anzeigenEuropean Interbalkan Medical Center, Οncology Department 57001 Thessaloniki GreeceAbgeschlossen» Google-MapsPrince of Wales Hospital Hong Kong Hong KongAktiv, nicht rekrutierend» Google-MapsQueen Mary Hospital Hong Kong Hong KongRekrutierend» Google-MapsSanta Maria delle Croci Hospital of Ravenna 48121 Ravenna ItalyZurückgezogen» Google-Maps"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano." 16132 Genoa ItalyZurückgezogen» Google-MapsPolish Mother's Memorial Hospital-Research Institute 93-338 Lodz PolandAbgeschlossen» Google-MapsBeata Głogowska 97-200 Tomaszów Mazowiecki PolandAbgeschlossen» Google-MapsInstitute of Genetics and Immunology GENIM LCC in Lublin 20-609 Lublin PolandAbgeschlossen» Google-MapsMalgorzata Kozlik 08-781 Warsaw PolandAbgeschlossen» Google-MapsMED-Polonia, Sp. z o.o. (LLC) 60-693 Poznan PolandAbgeschlossen» Google-MapsUniversity Hospital Nuestra Senora de Valme 41014 Sevilla SpainAbgeschlossen» Google-MapsHospital de la Santa Creu i Sant Pau 08041 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Laia I Lavernia Rossell E-Mail: LLavernia@santpau.cat» Ansprechpartner anzeigenHospital del Mar 089003 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Rosa I Lopez Parellada E-Mail: rlopezparellada@psmar.cat» Ansprechpartner anzeigenAnna Ramos Luna 08908 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Anna I Ramos Luna E-Mail: aramosl@idibell.cat» Ansprechpartner anzeigenUniversity Clinic of Navarra - Madrid 28027 Madrid SpainAktiv, nicht rekrutierend» Google-MapsUniversity Hospital 12 de Octubre 28041 Madrid SpainRekrutierend» Google-Maps Ansprechpartner: Maripaz Soriano E-Mail: unidadfase1.imas12@h12o.es» Ansprechpartner anzeigenKaohsiung Chang Gung Memorial Hospital Kaohsiung City TaiwanAbgeschlossen» Google-MapsNational Cheng Kung University Hospital Tainan TaiwanAbgeschlossen» Google-MapsNational Taiwan University Hospital Taipei City TaiwanRekrutierend» Google-Maps Ansprechpartner: Ying-Chun Liu E-Mail: 121630@ntuh.gov.tw» Ansprechpartner anzeigenLinKou Chang Gung Memorial Hospital Taoyuan City TaiwanRekrutierend» Google-Maps Ansprechpartner: Li-Ying Ou E-Mail: sherryou@hotmail.com» Ansprechpartner anzeigen
1. Phase 1: Safety Profile (Time Frame - Up to 24 months): Assess dose limiting toxicity as defined in the protocol
2. Phase 1: Safety Profile (Time Frame - Up to 24 months): Assess maximum tolerated dose as defined in the protocol
3. Phase 1 and 2: Safety Profile (Time Frame - Up to 24 months): Frequency and severity of AEs and/or SAEs
4. Phase 2: Confirmed Objective Response Rate (ORR) (Time Frame - Up to 24 months): Proportion of patients who achieve a confirmed CR or PR
Secondary outcome:
1. Phase 1: Pharmacokinetics (Time Frame - Up to 24 months): Plasma concentrations of ADC, total antibody and MMAE
2. Phase 1: Pharmacokinetics (Time Frame - Up to 24 months): Peak Plasma Concentration (Cmax)
3. Phase 1: Pharmacokinetics (Time Frame - Up to 24 months): Area under the plasma concentration versus time curve
4. Phase 1: Confirmed Objective Response Rate (ORR) (Time Frame - Up to 24 months): Proportion of patients who achieve a confirmed CR or PR
5. Phase 1: Immunogenicity (Time Frame - Up to 24 months): The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
6. Phase 1 and 2: Duration of response (DOR) (Time Frame - Up to 24 months): Time from the first documented OR until the first documented disease progression or death
(due to any cause), whichever occurs first
7. Phase 1 and 2: Progression-free survival (PFS) (Time Frame - Up to 24 months): Time from the first dose of IP until the first documentation of disease progression or
death due to any cause, whichever occurs first
8. Phase 1 and 2: Best overall response (OR) (Time Frame - Up to 24 months): All post-baseline disease assessments that occur prior to the initiation of subsequent
anticancer therapy
9. Phase 1 and 2: Disease control rate (DCR) (Time Frame - Up to 24 months): Proportion of patients with a best overall response of confirmed CR, confirmed PR, or
stable disease (SD) ≥ 12 weeks
10. Phase 1 and 2: Time to response (TTR) (Time Frame - Up to 24 months): Time from the first dose of investigational product until the first documentation of OR
11. Phase 1 and 2: Overall survival (OS) (Time Frame - Up to 24 months): Time from the first dose of BA3021 treatment until death due to any cause
12. Phase 1 and 2: Tumor size (Time Frame - Up to 24 months): Percent change from baseline in tumor size