Clinical trial • Phase III • Oncology
SACITUZUMAB TIRUMOTECAN for Urothelial carcinoma | Bladder cancer
Phase III trial of SACITUZUMAB TIRUMOTECAN for Urothelial carcinoma | Bladder cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Urothelial carcinoma | Bladder cancer
- Trial Stage
- Phase III
- Drug Modality
- ADC | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 09-12-2025
- First CTIS Authorization Date
- 20-04-2026
Trial design
Randomised, open-label, investigator's choice non-platinum chemotherapy: paclitaxel (up to 175 mg/m2, intravenous infusion), docetaxel (up to 75 mg/m2, intravenous infusion), vinflunine (up to 320 mg/m2, intravenous infusion) — schedule not specified in provided data.-controlled Phase III trial in Belgium, France, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Investigator's choice non-platinum chemotherapy: Paclitaxel (up to 175 mg/m2, intravenous infusion), Docetaxel (up to 75 mg/m2, intravenous infusion), Vinflunine (up to 320 mg/m2, intravenous infusion) — schedule not specified in provided data.
- Target Sample Size
- 274
Eligibility
Recruits 274 No vulnerable population selected. Standard informed consent from adult participants; no assent or paediatric consent procedures described..
- Vulnerable Population
- No vulnerable population selected. Standard informed consent from adult participants; no assent or paediatric consent procedures described.
Inclusion criteria
- {"criterion_text":"- Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment.\n- If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART).\n- If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load.\n- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n- Has adequate organ function.\n- Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator.\n- Has received treatment with anti-programmed cell death [ligand] 1 (anti-PD-[L]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV).\n- Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry.\n- Has received a maximum of 3 prior lines of therapy.\n- Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry.\n- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization.\n- Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine).\n- Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated."}
Exclusion criteria
- {"criterion_text":"- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n- Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine).\n- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n- Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis.\n- Has an active infection requiring systemic therapy other than those permitted per protocol.\n- Has a history of stem cell/solid organ transplant.\n- Has not adequately recovered from major surgery, or has ongoing surgical complications.\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.\n- Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy.\n- Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC).\n- Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC.\n- Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids.\n- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by investigator (as stated in secondary objectives)."}
- {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by investigator."}
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by investigator."}
- {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score","definition_or_measurement_approach":"Change from baseline in specified EORTC QLQ-C30 combined score (items 29 and 30)."}
- {"endpoint_text":"- Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score","definition_or_measurement_approach":"Change from baseline in specified EORTC QLQ-C30 physical functioning combined score (items 1-5)."}
- {"endpoint_text":"- Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score","definition_or_measurement_approach":"Change from baseline in specified EORTC QLQ-C30 role functioning combined score (items 6 and 7)."}
- {"endpoint_text":"- Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score","definition_or_measurement_approach":"Change from baseline in specified EORTC QLQ-C30 fatigue combined score (items 10, 12, 18)."}
- {"endpoint_text":"- Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score","definition_or_measurement_approach":"Change from baseline in specified EORTC QLQ-C30 nausea/vomiting combined score (items 14 and 15)."}
- {"endpoint_text":"- Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score","definition_or_measurement_approach":"Change from baseline in specified EORTC QLQ-C30 diarrhea score (item 17)."}
Recruitment
- Planned Sample Size
- 274
- Recruitment Window Months
- 47
- Consent Approach
- Informed consent obtained from participants using country-specific main consent forms. Main consent documents are provided in country-specific languages (examples in dossier: English, French, Dutch, German, Greek, Italian, Spanish, Swedish). No assent or paediatric consent procedures are described.
Geography
- Total Number Of Sites
- 59
- Total Number Of Participants
- 265
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- CHC MontLegia
- Department Name
- Oncology
- Contact Person Name
- Lyonel Herman
- Contact Person Email
- lyonel.herman@chc.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Oncology
- Contact Person Name
- Christof Vulsteke
- Contact Person Email
- Christof.vulsteke@mijnziekenhuis.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Contact Person Name
- Emmanual Seront
- Contact Person Email
- emmanuel.seront@saintluc.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Oncology
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- Sylvie.rottey@uzgent.be
France
- Earliest CTIS Part Ii Submission Date
- 05-03-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 47
- Number Of Sites
- 14
- Number Of Participants
- 80
Sites
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Contact Person Name
- Delphine BORCHIELLINI
- Contact Person Email
- delphine.borchiellini@nice.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology and Cellular Therapy
- Contact Person Name
- Mathieu JAMELOT
- Contact Person Email
- mathieu.jamelot@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Medical Oncology
- Contact Person Name
- Aline HOUESSINON
- Contact Person Email
- houessinon.aline@chu-amiens.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Oncology
- Contact Person Name
- Brigitte LAGUERRE
- Contact Person Email
- b.laguerre@rennes.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Nadine HOUEDE
- Contact Person Email
- nadine.houede@chu-nimes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology
- Contact Person Name
- Loïc JAFFRELOT
- Contact Person Email
- loic.jaffrelot@aphp.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Oncology
- Contact Person Name
- Hakim MAHAMMEDI
- Contact Person Email
- hakim.mahammedi@clermont.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncology
- Contact Person Name
- Aude FLECHON
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology
- Contact Person Name
- Charlotte JOLY
- Contact Person Email
- charlotte.joly@aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncology
- Contact Person Name
- Benjamin AUBERGER
- Contact Person Email
- benjamin.auberger@chu-brest.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Contact Person Name
- Yohann LORIOT
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Oncology
- Contact Person Name
- Marine GROSS-GOUPIL
- Contact Person Email
- marine.gross-goupil@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology
- Contact Person Name
- Constance THIBAUT
- Contact Person Email
- constance.thibault@aphp.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Contact Person Name
- Sylvain LADOIRE
- Contact Person Email
- sladoire@cgfl.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2026
- Latest Decision Or Authorization Date
- 25-04-2026
- Processing Time Days
- 44
- Number Of Sites
- 10
- Number Of Participants
- 34
Sites
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- Klinik für Urologie, Zentrum für Uro-Onkologie der Ruhr-Universität Bochum
- Contact Person Name
- Karl Tully
- Contact Person Email
- Karl.tully@elisabethgruppe.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik für Onkologie, II. Medizinische Klinik und Poliklinik
- Contact Person Name
- Gunhild von Amsberg
- Contact Person Email
- g.von-amsberg@uke.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Günter Niegisch
- Contact Person Email
- Guenter.Niegisch@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik f. Medizinische Onkologie
- Contact Person Name
- Stefanie Zschäbitz
- Contact Person Email
- stefanie.zschaebitz@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Marco Schnabel
- Contact Person Email
- mschnabel@csj.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Urologie und Kinderurologie
- Contact Person Name
- Friedemann Zengerling
- Contact Person Email
- Friedemann.Zengerling@uniklinik-ulm.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Klinik für Urologie und Transplantationschirurgie
- Contact Person Name
- Jens Bedke
- Contact Person Email
- j.bedke@klinikum-stuttgart.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Maria De Santis
- Contact Person Email
- maria.de-santis@charite.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- AöR des Freistaates Sachsen, Klinik und Poliklinik für Urologie
- Contact Person Name
- Severine Banek
- Contact Person Email
- severine.banek@ukdd.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Urologie
- Contact Person Name
- Martin Bögemann
- Contact Person Email
- Uroonkologie@ukmuenster.de
Greece
- Earliest CTIS Part Ii Submission Date
- 29-12-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 112
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- GU Department of Oncology
- Contact Person Name
- Marinos Tsiatas
- Contact Person Email
- tsiatas@hotmail.com
- Site Name
- General Oncological Hospital Of Kifissia Agioi Anargyroi
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Roubini Zakopoulou
- Contact Person Email
- rzakopoul@gmail.com
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd University Propaedeutic Pathology clinic
- Contact Person Name
- Aristotelis Bamias
- Contact Person Email
- abamias@med.uoa.gr
- Site Name
- Athens Medical Center S.A.
- Department Name
- 4th Department of Medical Oncology
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
- Site Name
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
- Department Name
- Oncologic Clinical Trials and Research Clinic
- Contact Person Name
- Evangelos Bournakis
- Contact Person Email
- vagimith@yahoo.com
Italy
- Earliest CTIS Part Ii Submission Date
- 29-12-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 113
- Number Of Sites
- 9
- Number Of Participants
- 32
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncologia Medica ed Ematologia
- Contact Person Name
- Paolo Zucali
- Contact Person Email
- paolo.zucali@cancercenter.humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Contact Person Name
- Roberto Iacovelli
- Contact Person Email
- roberto.iacovelli@policlinicogemelli.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Oncologia Medica 1
- Contact Person Name
- Giuseppe Fornarini
- Contact Person Email
- giuseppe.fornarini@hsanmartino.it
- Site Name
- Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa Oncologia Medica 1
- Contact Person Name
- Valentina Guadalupi
- Contact Person Email
- valentina.guadalupi@istitutotumori.mi.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Department Name
- Oncologia Medica
- Contact Person Name
- Alketa Hamzaj
- Contact Person Email
- alketa.hamzaj@uslsudest.toscana.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- UOC Oncologia
- Contact Person Name
- Sarah Scagliarini
- Contact Person Email
- sarah.scagliarini@aocardarelli.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Centro Ricerche Cliniche di Verona
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
- Site Name
- Ospedale Generale Provinciale Di Macerata
- Department Name
- UOC Oncologia
- Contact Person Name
- Nicola Battelli
- Contact Person Email
- nicola.battelli@sanita.marche.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- S.C.D.U. Oncologia Medica
- Contact Person Name
- Consuelo Buttigliero
- Contact Person Email
- consuelo.buttigliero@unito.it
Spain
- Earliest CTIS Part Ii Submission Date
- 26-03-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 29
- Number Of Sites
- 9
- Number Of Participants
- 49
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncología Médica
- Contact Person Name
- Pablo Gajate Borau
- Contact Person Email
- pgajateborau@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncología Médica
- Contact Person Name
- Javier Puente Vázquez
- Contact Person Email
- javierpuente.hcsc@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología Médica
- Contact Person Name
- Juan Martin Liberal
- Contact Person Email
- jmartinliberal@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Médica
- Contact Person Name
- Rafael Morales Barrera
- Contact Person Email
- rmorales@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncología Médica
- Contact Person Name
- Begoña Perez Valderrama
- Contact Person Email
- mbegona.perez.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncología Médica
- Contact Person Name
- Ignacio Durán Martínez
- Contact Person Email
- ignacioduranmartinez@gmail.com
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncología Médica
- Contact Person Name
- Alfonso Gómez de Liaño Lista
- Contact Person Email
- agomlis@gobiernodecanarias.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología Médica
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- cdanicas@hotmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncología Médica
- Contact Person Name
- Ignacio Durán Martínez
- Contact Person Email
- ignacioduranmartinez@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 19-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Region Joenkoepings Laen
- Department Name
- Onkologkliniken
- Contact Person Name
- Dimitrios Papantoniou
- Contact Person Email
- dimitrios.papantoniou@rjl.se
- Site Name
- Karolinska University Hospital
- Department Name
- Urologisk Onkologi
- Contact Person Name
- Anders Ullen
- Contact Person Email
- anders.ullen@regionstockholm.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 19-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Interne Oncologie / Medical Oncology
- Contact Person Name
- Debbie Robbrecht
- Contact Person Email
- interne.oncologie@erasmusmc.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Interne geneeskunde, medische oncologie
- Contact Person Name
- Maartje Los
- Contact Person Email
- interne-r&d@antoniusziekenhuis.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Interne geneeskunde
- Contact Person Name
- Elianne De Boer
- Contact Person Email
- rioc@isala.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Vakgroep Interne Geneeskunde
- Contact Person Name
- Michiel Van der Heijden
- Contact Person Email
- urologieinterne@nki.nl
- Site Name
- Stichting Elisabeth-TweeSteden Ziekenhuis
- Department Name
- Interne geneeskunde - Oncologie
- Contact Person Name
- Janneke Ham
- Contact Person Email
- trialbureau-onco@etz.nl
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Medical Oncology
- Contact Person Name
- Thomas Kerkhofs
- Contact Person Email
- secretariaat.medischeoncologie@mumc.nl
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Signant Health Global LLC
- Responsibilities
- sponsorDuties codes: 7
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services) (sponsorDuties code: 15)
- Name
- Iqvia Laboratories Limited
- Responsibilities
- sponsorDuties codes: 4
- Name
- Frontage Laboratories Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Bioclinica Inc.
- Responsibilities
- sponsorDuties codes: 4
Third parties
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services) (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ventana (Roche Tissue Diagnostics)","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- MK-2870
- Active Substance
- SACITUZUMAB TIRUMOTECAN
- Modality
- ADC | Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 1
- Maximum Dose
- 4 mg/kg
- Investigational Product Name
- DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 75 mg/m2
- Investigational Product Name
- VINFLUNINE
- Active Substance
- VINFLUNINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 320 mg/m2
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 175 mg/m2
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