Clinical trial • Phase II • Oncology
HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER for Peritoneal cancer | Ovarian cancer | Fallopian tube cancer
Phase II trial of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Peritoneal cancer | Ovarian cancer | Fallopian tube cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 12-03-2025
- First CTIS Authorization Date
- 07-07-2025
Trial design
Phase II trial across 39 sites in Austria, France, Germany and others.
- Biomarker Stratified
- True, CLDN6 expression (CLDN6-positive)
- Target Sample Size
- 76
Eligibility
Recruits 76 No vulnerable population selected; participants are adult females (aged 18 years or older). Informed consent documents and subject information forms are provided (multiple country/language ICFs available). No assent procedure required as only adults are eligible..
- Vulnerable Population
- No vulnerable population selected; participants are adult females (aged 18 years or older). Informed consent documents and subject information forms are provided (multiple country/language ICFs available). No assent procedure required as only adults are eligible.
Inclusion criteria
- {"criterion_text":"- Females aged 18 years or older with confirmed diagnosis of advanced (unresectable) or metastatic high grade serious ovarian, primary peritoneal (ie, of primary origin), or fallopian tube cancer that resistant to platinum-containing therapy.\n- Participant’s tumor must show CLDN6 expression, as defined by the CLDN6 reference laboratory assay.\n- Have measurable tumor at baseline\n- Based on their disease and availability in their region, participants must have received prior treatment with bevacizumab, mirvetuximab soravtansine, and/or a PARP inhibitor."}
Exclusion criteria
- {"criterion_text":"- Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers\n- Participants with primary platinum-refractory ovarian, primary peritoneal (ie, of primary origin) or fallopian tube cancer, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy\n- Still experiencing significant adverse events from previous cancer treatments\n- Recently received other cancer treatments (within 14 days for most drugs, or 28 days for biologics) before starting this new drug.\n- Has received treatment with a CLDN6-targeting agent or an monomethyl auristatin E (MMAE)-containing antibody drug conjugate"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as defined by confirmed best overall response of partial or complete responses) by blinded independent central review (BICR).","definition_or_measurement_approach":"ORR per RECIST v1.1 defined by confirmed best overall response of partial or complete responses, assessed by blinded independent central review (BICR)."}
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent is obtained from adult participants (females aged 18 years or older). Subject information and informed consent form documents are provided (Main ICF, Prescreen ICF, Pregnancy ICF and related materials) and are available in multiple country/language versions as evidenced by country-specific ICF documents (e.g. EN, FR, DE, IT, ES, NL, CZ). No assent procedures are indicated since only adults are eligible.
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 159
Austria
- Earliest CTIS Part Ii Submission Date
- 25-06-2025
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 316
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Gynecology and Obstetrics
- Principal Investigator Name
- Nicole Concin
- Principal Investigator Email
- nicole.concin@meduniwien.ac.at
- Contact Person Name
- Nicole Concin
- Contact Person Email
- nicole.concin@meduniwien.ac.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Gynecology and Obstetrics
- Principal Investigator Name
- Vassiliki Kolovetsiu-Kreiner
- Principal Investigator Email
- vassiliki.kolovetsiu@medunigraz.at
- Contact Person Name
- Vassiliki Kolovetsiu-Kreiner
- Contact Person Email
- vassiliki.kolovetsiu@medunigraz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Department of Gynecology and Obstetrics
- Principal Investigator Name
- Christian Marth
- Principal Investigator Email
- christian.marth@tirol-kliniken.at
- Contact Person Name
- Christian Marth
- Contact Person Email
- christian.marth@tirol-kliniken.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Gynecology
- Principal Investigator Name
- Judith Lafleur
- Principal Investigator Email
- judith.lafleur@ordensklinikum.at
- Contact Person Name
- Judith Lafleur
- Contact Person Email
- judith.lafleur@ordensklinikum.at
France
- Earliest CTIS Part Ii Submission Date
- 07-06-2025
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 332
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Olivia LE SAUX
- Principal Investigator Email
- Olivia.lesaux@lyon.unicancer.fr
- Contact Person Name
- Olivia LE SAUX
- Contact Person Email
- Olivia.lesaux@lyon.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-Sébastien Frenel
- Principal Investigator Email
- Jean-sebastien.frenel@ico.unicancer.fr
- Contact Person Name
- Jean-Sébastien Frenel
- Contact Person Email
- Jean-sebastien.frenel@ico.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alexandra Leary
- Principal Investigator Email
- alexandra.leary@gustaveroussy.fr
- Contact Person Name
- Alexandra Leary
- Contact Person Email
- alexandra.leary@gustaveroussy.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-06-2025
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 328
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Department of Gynecology and Obstetrics
- Principal Investigator Name
- Julius Emons
- Principal Investigator Email
- fk-management-cru@uk-erlangen.de
- Contact Person Name
- Julius Emons
- Contact Person Email
- fk-management-cru@uk-erlangen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Department of Gynecology
- Principal Investigator Name
- Barbara Schmalfeldt
- Principal Investigator Email
- frauenklinik@uke.de
- Contact Person Name
- Barbara Schmalfeldt
- Contact Person Email
- frauenklinik@uke.de
- Site Name
- Heidelberg University
- Department Name
- Department of Gynecologic Oncology
- Principal Investigator Name
- Frederic Marmé
- Principal Investigator Email
- frauenklinik@umm.de
- Contact Person Name
- Frederic Marmé
- Contact Person Email
- frauenklinik@umm.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department of Women's Health
- Principal Investigator Name
- Annika Simma (nee Rohner)
- Principal Investigator Email
- Annika.simma@med.uni-tuebingen.de
- Contact Person Name
- Annika Simma (nee Rohner)
- Contact Person Email
- Annika.simma@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Department of Gynecologic Oncology
- Principal Investigator Name
- Katharina Smetanay
- Principal Investigator Email
- Frauenklinik.Ambulanz.Onkologie@med.uni-heidelberg.de
- Contact Person Name
- Katharina Smetanay
- Contact Person Email
- Frauenklinik.Ambulanz.Onkologie@med.uni-heidelberg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Gynecology
- Principal Investigator Name
- Klaus Pietzner
- Principal Investigator Email
- gyn-studien@charite.de
- Contact Person Name
- Klaus Pietzner
- Contact Person Email
- gyn-studien@charite.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-04-2025
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 394
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Jessa Ziekenhuis
- Department Name
- Oncology
- Principal Investigator Name
- Eric Joosens
- Principal Investigator Email
- eric.joosens@jessazh.be
- Contact Person Name
- Eric Joosens
- Contact Person Email
- eric.joosens@jessazh.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Medical oncology & hematology
- Principal Investigator Name
- Delphine Schampers
- Principal Investigator Email
- Delphine.schampers@mijnziekenhuis.be
- Contact Person Name
- Delphine Schampers
- Contact Person Email
- Delphine.schampers@mijnziekenhuis.be
- Site Name
- UZ Leuven
- Department Name
- Gynaecological Oncology
- Principal Investigator Name
- Toon Van Gorp
- Principal Investigator Email
- Toon.vangorp@uzleuven.be
- Contact Person Name
- Toon Van Gorp
- Contact Person Email
- Toon.vangorp@uzleuven.be
- Site Name
- Cliniques universitaires Saint-Luc - Université Catholique Louvain
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-François Baurain
- Principal Investigator Email
- jean-francois.baurain@saintluc.uclouvain.be
- Contact Person Name
- Jean-François Baurain
- Contact Person Email
- jean-francois.baurain@saintluc.uclouvain.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Medical Oncology
- Principal Investigator Name
- Christine Gennigens
- Principal Investigator Email
- christine.gennigens@chuliege.be
- Contact Person Name
- Christine Gennigens
- Contact Person Email
- christine.gennigens@chuliege.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sevilay Altintas
- Principal Investigator Email
- sevilay.altintas@uza.be
- Contact Person Name
- Sevilay Altintas
- Contact Person Email
- sevilay.altintas@uza.be
Italy
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 349
- Number Of Sites
- 6
- Number Of Participants
- 32
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Ginecologia oncologica
- Principal Investigator Name
- Anna Fagotti
- Principal Investigator Email
- anna.fagotti@policlinicogemelli.it
- Contact Person Name
- Anna Fagotti
- Contact Person Email
- anna.fagotti@policlinicogemelli.it
- Site Name
- Azienda USL Toscana Centro
- Department Name
- SOC Oncologia Media
- Principal Investigator Name
- Elena Zafarana
- Principal Investigator Email
- elena.zafarana@uslcentro.toscana.it
- Contact Person Name
- Elena Zafarana
- Contact Person Email
- elena.zafarana@uslcentro.toscana.it
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- Medical Oncology
- Principal Investigator Name
- Emanuele Naglieri
- Principal Investigator Email
- emanuele.naglieri@gmail.com
- Contact Person Name
- Emanuele Naglieri
- Contact Person Email
- emanuele.naglieri@gmail.com
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Medical Oncology Unit 1
- Principal Investigator Name
- Valeria Andretta
- Principal Investigator Email
- Valeria.andretta@hsanmartino.it
- Contact Person Name
- Valeria Andretta
- Contact Person Email
- Valeria.andretta@hsanmartino.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Ginecologia Oncologica Medica
- Principal Investigator Name
- Domenica Lorusso
- Principal Investigator Email
- domenica.lorusso@hunimed.eu
- Contact Person Name
- Domenica Lorusso
- Contact Person Email
- domenica.lorusso@hunimed.eu
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
- Principal Investigator Name
- Sabrina Chiara Cecere
- Principal Investigator Email
- s.cecere@istitutotumori.na.it
- Contact Person Name
- Sabrina Chiara Cecere
- Contact Person Email
- s.cecere@istitutotumori.na.it
Ireland
- Earliest CTIS Part Ii Submission Date
- 29-05-2025
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 347
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- St James's Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Karen Cadoo
- Principal Investigator Email
- research@stjames.ie
- Contact Person Name
- Karen Cadoo
- Contact Person Email
- research@stjames.ie
- Site Name
- Cork University Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Dearbhaile Collins
- Principal Investigator Email
- mary.glass@hse.ie
- Contact Person Name
- Dearbhaile Collins
- Contact Person Email
- mary.glass@hse.ie
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Austin Duffy
- Principal Investigator Email
- amy.slater@startdublin.com
- Contact Person Name
- Austin Duffy
- Contact Person Email
- amy.slater@startdublin.com
- Site Name
- University Hospital Galway
- Department Name
- Medical Oncology
- Principal Investigator Name
- Michael McCarthy
- Principal Investigator Email
- yoursay@hse.ie
- Contact Person Name
- Michael McCarthy
- Contact Person Email
- yoursay@hse.ie
Spain
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 376
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- Institut Catala D'oncologia (L'hospitalet De Llobregat)
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Beatriz Pardo Burdalo
- Principal Investigator Email
- bpardo@iconcologia.net
- Contact Person Name
- Beatriz Pardo Burdalo
- Contact Person Email
- bpardo@iconcologia.net
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ana OAKNIN BENZAQUEN
- Principal Investigator Email
- ana.oaknin@salud.madrid.org
- Contact Person Name
- Ana OAKNIN BENZAQUEN
- Contact Person Email
- ana.oaknin@salud.madrid.org
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Pilar Barretina Ginesta
- Principal Investigator Email
- contactfortrialsicogir@iconcologia.net
- Contact Person Name
- Maria Pilar Barretina Ginesta
- Contact Person Email
- contactfortrialsicogir@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology Service
- Principal Investigator Name
- Carmen Garcia Duran
- Principal Investigator Email
- cgarciaduran@vhio.net
- Contact Person Name
- Carmen Garcia Duran
- Contact Person Email
- cgarciaduran@vhio.net
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Casado Herraez
- Principal Investigator Email
- Antonio.casado@salud.madrid.org
- Contact Person Name
- Antonio Casado Herraez
- Contact Person Email
- Antonio.casado@salud.madrid.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Principal Investigator Name
- Eva Maria Guerra Alia
- Principal Investigator Email
- evamaria.guerra@salud.madrid.org
- Contact Person Name
- Eva Maria Guerra Alia
- Contact Person Email
- evamaria.guerra@salud.madrid.org
Czechia
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 335
- Number Of Sites
- 4
- Number Of Participants
- 19
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Gynekologicko-porodnická kliniky
- Principal Investigator Name
- Jan Kümmel
- Principal Investigator Email
- info.lf@osu.cz
- Contact Person Name
- Jan Kümmel
- Contact Person Email
- info.lf@osu.cz
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- Gynekologicko-porodnická klinika
- Principal Investigator Name
- Michael Zikán
- Principal Investigator Email
- info@bulovka.cz
- Contact Person Name
- Michael Zikán
- Contact Person Email
- info@bulovka.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Gynekologicko-porodnická kliniky
- Principal Investigator Name
- David Cibula
- Principal Investigator Email
- info@apolinar.eu
- Contact Person Name
- David Cibula
- Contact Person Email
- info@apolinar.eu
- Site Name
- Nemocnice AGEL Novy Jicin a.s.
- Department Name
- Komplexní onkologické centrum
- Principal Investigator Name
- Vojtěch Tlustý
- Principal Investigator Email
- sekretariat@nnj.agel.cz
- Contact Person Name
- Vojtěch Tlustý
- Contact Person Email
- sekretariat@nnj.agel.cz
Sponsor
Primary sponsor
- Full Name
- Torl Biotherapeutics LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- PK and ADA analysis
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Medicial and Regulatory writing
- Name
- Iqvia Laboratories Limited
- Responsibilities
- FOLR1 Testing
- Name
- Suvoda LLC
- Name
- BioClinica GmbH
- Responsibilities
- Management of Central Imaging Reads/Central Analysis, Quality Assessments, Query Management, Study Metrics/Reporting, Data Transfer
- Name
- Labcorp
- Responsibilities
- FOLR1 Testing
Third parties
- {"country":"France","full_name":"Novasco","duties_or_roles":"France sites only - site payments and patient reimbursement","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"PK and ADA analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"ADA + Sample Analysis and Storage","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Elevation Strategic Development UK Limited","duties_or_roles":"Consulting - Diagnostic development","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"EU QP - IMP Management","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Fundacion Grupo Espanol De Investigacion En Cancer De Mama","duties_or_roles":"Local operational support for translations and site contracting during trial start-up.","organisation_type":"Patient organisation/association"}
- {"country":"Canada","full_name":"Translational Research In Oncology","duties_or_roles":"E data capture via Rave Medidata, and site payment reimbursements.","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"Tissue samples testing lab","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"Kits provision, samples collection and shipment for ADA and PK testing.","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"BioClinica GmbH","duties_or_roles":"Management of Central Imaging Reads/Central Analysis, Quality Assessments, Query Management, Study Metrics/Reporting, Data Transfer","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Site payments and patient reimbursements.","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Therainnova AG","duties_or_roles":"ODD and SME regulatory support services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"FOLR1 Testing","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Luxembourg","full_name":"Insight Drug Regulatory","duties_or_roles":"ODD Support & SME Status","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"Hungarotrial Zrt.","duties_or_roles":"Local operational support for translations and site contracting during trial start-up.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Vanadro LLC","duties_or_roles":"Analysis of PK data (at start-up)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Medicial and Regulatory writing","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"Start-up operational support for translations and site contracting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"FOLR1 Testing","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- TORL-1-23
- Active Substance
- HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER
- Modality
- ADC
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Orphan Designation
- Yes
- Maximum Dose
- 3.4 mg/kg
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