Clinical trial • Phase II • Oncology
DISITAMAB VEDOTIN for Head and neck cancer|Ovarian cancer|Non-small cell lung cancer|Endometrial cancer
Phase II trial of DISITAMAB VEDOTIN for Head and neck cancer|Ovarian cancer|Non-small cell lung cancer|Endometrial cancer. open-label. 132 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Head and neck cancer|Ovarian cancer|Non-small cell lung cancer|Endometrial cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 08-02-2024
- First CTIS Authorization Date
- 28-05-2024
Trial design
open-label Phase II trial across 18 sites in France, Germany, Spain and others.
- Open Label
- Yes
- Target Sample Size
- 132
- Trial Duration For Participant
- 1417
Eligibility
Recruits 132 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling for vulnerable participants are provided in the CTIS record or available documents text..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling for vulnerable participants are provided in the CTIS record or available documents text.
Inclusion criteria
- {"criterion_text":"- Cohort 1: HNC •Must have pathologically-documented carcinoma of the head and neck with primary tumor site arising from the oral cavity, salivary gland, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded. •Unresectable locally recurrent or metastatic stage disease •Prior therapies: -Participants must have disease progression after treatment with a platinum-based therapy or other first line treatment regimen\n- Cohort 2: NSCLC •Pathologically documented NSCLC •Unresectable locally-advanced or metastatic stage disease •Prior therapies: -Must have progressed during or after a platinum-based therapy or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease -Must have received prior anti-PD(L)1 therapy, unless contraindicated - Participants with known AGAs must have received appropriate targeted therapy, where available -No more than 2 prior lines of cytotoxic chemotherapy for advanced disease\n- Cohort 3: Ovarian Cancer •Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin •Unresectable locally-advanced or metastatic stage disease •Prior therapies -Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence) -Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease -May have received prior anti-PD(L)1 therapy\n- Cohort 4: Endometrial Cancer •Must have pathologically documented adenocarcinoma of the endometrium •Must have unresectable locally-advanced or metastatic stage disease. •Prior therapies: -Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease -Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease -May have received prior anti-PD(L)1 therapy\n- HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue. Note: Subjects with HER2 mutations are eligible.\n- Measurable disease per RECIST v1.1 criteria as assessed by the investigator.\n- Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides).\n- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with an MMAE-containing agent\n- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin\n- History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy\n- Active untreated CNS or leptomeningeal metastasis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator.","definition_or_measurement_approach":"ORR measured per RECIST v1.1 as assessed by the investigator (confirmed responses per RECIST v1.1)."}
Secondary endpoints
- {"endpoint_text":"- Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) including AEs of special interest (AESIs).\n- Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline\n- Frequency of treatment interruptions, dose reductions and treatment discontinuations due to AEs.\n- Confirmed disease control rate (DCR) per RECIST v1.1 as assessed by the investigator\n- Duration of response (DOR) per RECIST v1.1 as assessed by the investigator\n- Progression free survival (PFS) per RECIST v1.1 as assessed by the investigator\n- Overall survival (OS)\n- Select PK parameters of disitamab vedotin, total antibody (TAb) and unconjugated MMAE\n- Incidence of antidrug antibodies (ADA) against disitamab vedotin","definition_or_measurement_approach":"AEs: recorded by type, incidence, severity, seriousness and relatedness (standard AE reporting); laboratory abnormalities: changes from baseline and severity grading; treatment interruptions/dose reductions/discontinuations: frequency due to AEs; DCR/ORR/DOR/PFS assessed per RECIST v1.1 by investigator; OS: survival status; PK endpoints: select PK parameters for disitamab vedotin, total antibody (TAb) and unconjugated MMAE; ADA: incidence of antidrug antibodies against disitamab vedotin."}
Recruitment
- Planned Sample Size
- 132
- Recruitment Window Months
- 46
- Consent Approach
- Informed consent documents (subject information and informed consent forms) are provided; CTIS document list includes ICF and SIS documents in multiple languages (e.g. German, Spanish, Italian) and pre-screening ICFs. Consent is obtained from adult participants. No additional details on assent, consent from legal representatives, or specific language/version handling beyond the presence of country-specific ICF documents are provided in the CTIS record.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 28
France
- Earliest CTIS Part Ii Submission Date
- 02-05-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 32
- Number Of Sites
- 6
- Number Of Participants
- 7
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sylvie Zanetta
- Principal Investigator Email
- szanetta@cgfl.fr
- Contact Person Name
- Sylvie Zanetta
- Contact Person Email
- szanetta@cgfl.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Dominique Berton
- Principal Investigator Email
- dominique.berton@ico.unicancer.fr
- Contact Person Name
- Dominique Berton
- Contact Person Email
- dominique.berton@ico.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Urology and Clinical Research
- Principal Investigator Name
- Elodie Coquan
- Principal Investigator Email
- e.coquan@baclesse.unicancer.fr
- Contact Person Name
- Elodie Coquan
- Contact Person Email
- e.coquan@baclesse.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Department of Medicine
- Principal Investigator Name
- Alexandra Leary
- Principal Investigator Email
- alexandra.leary@gustaveroussy.fr
- Contact Person Name
- Alexandra Leary
- Contact Person Email
- alexandra.leary@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Isabelle Ray-Coquard
- Principal Investigator Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Contact Person Name
- Isabelle Ray-Coquard
- Contact Person Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Medical Oncology
- Principal Investigator Name
- Amaury Daste
- Principal Investigator Email
- amaury.daste@chu-bordeaux.fr
- Contact Person Name
- Amaury Daste
- Contact Person Email
- amaury.daste@chu-bordeaux.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 23-04-2024
- Latest Decision Or Authorization Date
- 23-04-2025
- Processing Time Days
- 365
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Johanniter GmbH
- Department Name
- Internal medicine
- Principal Investigator Name
- Yon-Dschun Ko
- Principal Investigator Email
- Yon-Dschun.Ko@bn.johanniter-kliniken.de
- Contact Person Name
- Yon-Dschun Ko
- Contact Person Email
- Yon-Dschun.Ko@bn.johanniter-kliniken.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- hematology, oncology and tumorimmunology department
- Principal Investigator Name
- Damian Rieke
- Principal Investigator Email
- Damian.rieke@charite.de
- Contact Person Name
- Damian Rieke
- Contact Person Email
- Damian.rieke@charite.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Department of Gynaecology & Gynaecological Oncology
- Principal Investigator Name
- Florian Heitz
- Principal Investigator Email
- f.heitz@kem-med.com
- Contact Person Name
- Florian Heitz
- Contact Person Email
- f.heitz@kem-med.com
Spain
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 23-04-2025
- Processing Time Days
- 352
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Rosa Maria Rodriguez Alonso
- Principal Investigator Email
- rosarodriguezalonso@gmail.com
- Contact Person Name
- Rosa Maria Rodriguez Alonso
- Contact Person Email
- rosarodriguezalonso@gmail.com
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncology
- Principal Investigator Name
- Antonio Gonzalez Martin
- Principal Investigator Email
- agonzalezma@unav.es
- Contact Person Name
- Antonio Gonzalez Martin
- Contact Person Email
- agonzalezma@unav.es
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncology
- Principal Investigator Name
- Antonio Gonzalez Martin
- Principal Investigator Email
- agonzalezma@unav.es
- Contact Person Name
- Antonio Gonzalez Martin
- Contact Person Email
- agonzalezma@unav.es
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Principal Investigator Name
- Maria Martinez Garcia
- Principal Investigator Email
- mariamartinezgarcia@parcdesalutmar.cat
- Contact Person Name
- Maria Martinez Garcia
- Contact Person Email
- mariamartinezgarcia@parcdesalutmar.cat
Italy
- Earliest CTIS Part Ii Submission Date
- 19-04-2024
- Latest Decision Or Authorization Date
- 23-04-2025
- Processing Time Days
- 369
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- Giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- Giuseppe.curigliano@ieo.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Michele Milella
- Principal Investigator Email
- michele.milella@aovr.veneto.it
- Contact Person Name
- Michele Milella
- Contact Person Email
- michele.milella@aovr.veneto.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Medical Oncology
- Principal Investigator Name
- Valentina Guarneri
- Principal Investigator Email
- valentina.guarneri@unipd.it
- Contact Person Name
- Valentina Guarneri
- Contact Person Email
- valentina.guarneri@unipd.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Stefania Canova
- Principal Investigator Email
- stefania.canova@irccs-sangerardo.it
- Contact Person Name
- Stefania Canova
- Contact Person Email
- stefania.canova@irccs-sangerardo.it
Sponsor
Primary sponsor
- Full Name
- Seagen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Patient Non-Advocacy; Medical Imaging
- Name
- PPD Development LP
- Responsibilities
- ADC, ADA, TaB, NAb Testing
- Name
- 4g Clinical LLC
- Responsibilities
- Randomization and Trial Supply Management (RTSM) Interactive Response Technology (IRT)
- Name
- WCG Clinical Inc.
- Responsibilities
- Feasibility
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Patient Non-Advocacy","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"PK and Free MMAE Testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Tissue DNA & RNA analysis and storage – global","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Drug Packaging, Labeling, Distribution, QP","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Medical Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Bulk shipments to other depots will be supported from this depot or FCS Basel for France, Germany, Italy, Spain","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Distribution.orders: EU site returns sent to this depot","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Randomization and Trial Supply Management (RTSM) Interactive Response Technology (IRT)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Stark Raving LLC","duties_or_roles":"Branded Materials","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Feasibility","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"HER2 Analysis of Tumor Tissue","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Subject Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab (Provides lab kits and receives/stores exploratory specimens)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"ADC, ADA, TaB, NAb Testing","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Disitamab Vedotin
- Active Substance
- DISITAMAB VEDOTIN
- Modality
- ADC
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Maximum Dose
- 150 mg
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