Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
235
Countries
8
Sites
39
Peritoneal Cancer
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced (PROC) expressing CLDN6
Key facts
- Sponsor
- Torl Biotherapeutics LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Sep 2025 → ongoing
- Decision date (initial)
- 2025-07-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- TORL BioTherapeutics LLC
External identifiers
- EU CT number
- 2024-517190-24-00
- ClinicalTrials.gov
- NCT06690775
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Efficacy
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced (PROC) expressing CLDN6
Conditions and MedDRA coding
Peritoneal Cancer
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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.
- Participant’s tumor must show CLDN6 expression, as defined by the CLDN6 reference laboratory assay.
- Have measurable tumor at baseline
- 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 5
- Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers
- 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
- Still experiencing significant adverse events from previous cancer treatments
- Recently received other cancer treatments (within 14 days for most drugs, or 28 days for biologics) before starting this new drug.
- Has received treatment with a CLDN6-targeting agent or an monomethyl auristatin E (MMAE)-containing antibody drug conjugate
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11819092 · Product
- Active substance
- Humanised IGG1 Monoclonal Antibody Against CLDN6 Conjugated to Monomethyl Auristatin E via a Cathepsin Hydrolysable Dipeptide Vc Linker
- Pharmaceutical form
- LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 3.4 mg/kg milligram(s)/kilogram
- Max total dose
- 119 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TORL BIOTHERAPEUTICS LLC
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000142281
Auxiliary 1
SCP180112 · ATC
- Active substance
- Glatiramer Acetate
- Substance synonyms
- COPOLYMER-1
- Route of administration
- INJECTION
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 210 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L03AA13 — PEGFILGRASTIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Torl Biotherapeutics LLC
- Sponsor organisation
- Torl Biotherapeutics LLC
- Address
- 6100 Bristol Parkway
- City
- Culver City
- Postcode
- 90230-6604
- Country
- United States
Scientific contact point
- Organisation
- Torl Biotherapeutics LLC
- Contact name
- TORL Clinical Trial Information
Public contact point
- Organisation
- Torl Biotherapeutics LLC
- Contact name
- TORL Clinical Trial Information
Third parties 21
| Organisation | City, country | Duties |
|---|---|---|
| Novasco ORG-100046671
|
Paris, France | Other |
| Syneos Health Inc. ORG-100008382
|
Princeton, United States | Other, Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Morrisville, United States | Other |
| Elevation Strategic Development UK Limited ORG-100054036
|
Dewsbury, United Kingdom | Other |
| Catalent Germany Schorndorf GmbH ORG-100011845
|
Schorndorf, Germany | Other |
| Fundacion Grupo Espanol De Investigacion En Cancer De Mama ORG-100010747
|
San Sebastian De Los Reyes, Spain | Other |
| Translational Research In Oncology ORG-100011285
|
Edmonton, Canada | On site monitoring, Code 12, Other, Code 2, Code 5, Data management, E-data capture, Code 8 |
| University Medical Center Hamburg-Eppendorf ORG-100008810
|
Hamburg, Germany | Other |
| LabConnect GmbH ORG-100047696
|
Cologne, Germany | Other |
| BioClinica GmbH ORG-100032790
|
Munich, Germany | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Therainnova AG ORG-100045892
|
Forch, Switzerland | Other |
| Edetek Inc. ORG-100045957
|
Princeton, United States | Code 10 |
| Iqvia Laboratories Limited ORG-100042527
|
Livingston, United Kingdom | Other |
| Insight Drug Regulatory ORG-100041677
|
Luxembourg, Luxembourg | Other |
| Hungarotrial Zrt. ORG-100026530
|
Budapest XI, Hungary | Other |
| Vanadro LLC ORG-100056381
|
West Des Moines, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 11, Code 12, Other |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Labcorp ORG-100011514
|
Durham, United States | Other |
Locations
8 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 12 | 4 |
| Belgium | Ongoing, recruiting | 21 | 6 |
| Czechia | Ongoing, recruiting | 19 | 4 |
| France | Ongoing, recruiting | 21 | 3 |
| Germany | Ongoing, recruiting | 15 | 6 |
| Ireland | Ongoing, recruiting | 21 | 4 |
| Italy | Ongoing, recruiting | 32 | 6 |
| Spain | Ongoing, recruiting | 18 | 6 |
| Rest of world
Korea, Republic of, Australia, Singapore, Canada, United States
|
— | 76 | — |
Investigational sites
Medical University Of Graz
Department of Gynecology and Obstetrics, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University Of Vienna
Department of Gynecology and Obstetrics, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Department of Gynecology and Obstetrics, Anichstrasse 35, 6020, Innsbruck
Ordensklinikum Linz GmbH
Department of Gynecology, Seilerstaette 4, 4010, Linz
Cliniques universitaires Saint-Luc - Université Catholique Louvain
Medical Oncology, Avenue Hippocrate 10, 1200, BRUSSELS
Centre hospitalier universitaire de Liege
Medical Oncology, Avenue De L'Hopital 1, 4000, Liege
Universitair Ziekenhuis Antwerpen
Medical Oncology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Gynaecological Oncology, Herestraat 49, 3000, Leuven
Az Maria Middelares Gent
Medical oncology & hematology, Buitenring-Sint-Denijs 30, 9000, Gent
Jessa Ziekenhuis
Oncology, Salvatorstraat 20, 3500, Hasselt
Fakultni Nemocnice Ostrava
Gynekologicko-porodnická kliniky, 17. Listopadu 1790/5, Poruba, Ostrava
Vseobecna Fakultni Nemocnice V Praze
Gynekologicko-porodnická kliniky, Apolinarska 441/18 Nove Mesto, 128 00, Prague
Fakultni Nemocnice Bulovka
Gynekologicko-porodnická klinika, Budinova 67/2, Liben, Prague
Nemocnice AGEL Novy Jicin a.s.
Komplexní onkologické centrum, Purkynova 2138/16, 741 01, Novy Jicin
Centre Leon Berard
Department of Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
University Medical Center Hamburg-Eppendorf
Department of Gynecology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Heidelberg AöR
Department of Gynecologic Oncology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Heidelberg University
Department of Gynecologic Oncology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Charite Universitaetsmedizin Berlin KöR
Department of Gynecology, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Erlangen AöR
Department of Gynecology and Obstetrics, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Universitaetsklinikum Tuebingen AöR
Department of Women's Health, Calwerstrasse 7, Innenstadt, Tuebingen
Mater Misericordiae University Hospital
Medical Oncology, Eccles Street, D07 R2WY, Dublin 7
St James's Hospital
Medical Oncology, James's Street, D08 NHY1, Dublin 8
Cork University Hospital
Medical Oncology, Wilton, T12 DC4A, Cork
University Hospital Galway
Medical Oncology, Newcastle Road, H91 YR71, Galway
IRCCS Ospedale Policlinico San Martino
Medical Oncology Unit 1, Largo Rosanna Benzi 10, 16132, Genoa
Azienda USL Toscana Centro
SOC Oncologia Media, Via Suor Niccolina Infermiera 20/22, 59100, Prato
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Clinica Sperimentale Uro-Ginecologica, Via Mariano Semmola 52, 80131, Naples
Istituto Tumori Bari Giovanni Paolo II
Medical Oncology, Viale Orazio Flacco 65, 70124, Bari
Humanitas Mirasole S.p.A.
Ginecologia Oncologica Medica, Via Francesco Nava 31, 20159, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ginecologia oncologica, Largo Francesco Vito 1, 00168, Rome
Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology Service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Medical Oncology, Avinguda De Franca S/n, 17007, Girona
Institut Catala D'oncologia
Medical Oncology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-10-01 | 2025-12-19 | |||
| Belgium | 2025-09-16 | 2025-09-19 | |||
| Czechia | 2026-01-08 | 2026-02-02 | |||
| France | 2025-10-29 | 2025-10-30 | |||
| Germany | 2025-10-24 | 2025-12-18 | |||
| Ireland | 2025-09-16 | 2025-09-16 | |||
| Italy | 2025-09-16 | 2025-09-18 | |||
| Spain | 2025-11-28 | 2026-02-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 115 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517190-24-00_Redacted | 5 |
| Recruitment arrangements (for publication) | K1_TORL123-002_AUT_Recruitment arrangement | 0 |
| Recruitment arrangements (for publication) | K1_TORL123-002_BEL_Recruitment Arrangement | 0 |
| Recruitment arrangements (for publication) | K1_TORL123-002_CZE_Recruitment and Informed consent procedure | 0 |
| Recruitment arrangements (for publication) | K1_TORL123-002_DEU_Recruitment Arrangement | 0 |
| Recruitment arrangements (for publication) | K1_TORL123-002_ESP_Recruitment-Arrangements | 0 |
| Recruitment arrangements (for publication) | K1_TORL123-002_IRL_Recruitment-Arrangements | 0 |
| Recruitment arrangements (for publication) | K1_TORL123-002_ITA_Recruitment arranegments | 0 |
| Recruitment arrangements (for publication) | K1_TORL23-002_FRA_Recruitment Arrangement | 0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_AUT_Leftover ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_AUT_Main ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_AUT_Pregnancy ICF_Redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_AUT_Prescreening ICF_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_AUT_Site Contact Details | 2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_AUT_TBDP ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL_Pregnancy ICF_NL | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Leftover Specimen ICF_DE_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Leftover Specimen ICF_EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Leftover Specimen ICF_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Leftover Specimen ICF_NL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Main ICF_DE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Main ICF_EN_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Main ICF_FR_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Main ICF_NL_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Pregnancy ICF_DE | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Pregnancy ICF_EN | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Pregnancy ICF_FR | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Prescreen ICF_DE | 2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Prescreen ICF_EN | 2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Prescreen ICF_FR | 2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-Prescreen ICF_NL | 2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-TBP ICF_DE_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-TBP ICF_EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-TBP ICF_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_BEL-TBP ICF_NL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_CZE_GDPR ICF | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_CZE_Leftover ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_CZE_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_CZE_Pregnancy ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_CZE_Prescreen ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_CZE_TBDP ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_DEU_Leftover ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_DEU_Main ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_DEU_Pregnancy ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_DEU_Prescreening ICF_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_DEU_TBDP ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ESP_Consent-Withdrawal_SPA | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ESP_Leftover-Samples-PICF_SPA_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ESP_Main-PICF_SPA_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ESP_Pregnancy-PICF_SPA | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ESP_Prescreen-PICF_SPA_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ESP_TBDP-PICF_SPA_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_FRA_Infant ICF_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_FRA_Leftover Specimen ICF_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_FRA_Main ICF_FR_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_FRA_Pregnancy ICF_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_FRA_Prescreen ICF_FR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_FRA_TBP ICF_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_IRL_Leftover-Samples-PICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_IRL_Main-PICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_IRL_Pregnancy-PICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_IRL_Prescreen-PICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_IRL_TBDP-PICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ITA_LO Specimen ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ITA_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ITA_Pregnancy ICF | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ITA_Prescreening ICF | 1 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ITA_Prescreening ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_TORL123-002_ITA_TBP ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_BEL_Patient card_DE | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_BEL_Patient card_EN | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_BEL_Patient card_FR | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_BEL_Patient card_NL | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_ESP_Patient-Notice_ES | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_FRA_Patient card | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_IRL_Patient-Card | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_IRL_Patient-Notice | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_ITA_GP letter | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_ITA_Patient card | 1 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_CZ | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_DE | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_DE | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_DE | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_EN | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_EN | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_ES | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_FR | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_FR | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_IT | 0 |
| Subject information and informed consent form (for publication) | L2_TORL123-002_Patient Education Card_NL | 0 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_AUT_GP Letter | 0 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_AUT_Patient card | 1 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_BEL_Payment Reimbursement Notice_DE | 10.3 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_BEL_Payment Reimbursement Notice_EN | 10.3 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_BEL_Payment Reimbursement Notice_FR | 10.3 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_BEL_Payment Reimbursement Notice_NL | 10.3 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_CZE_GP letter template | 0 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_CZE_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_DEU_GP Letter | 0 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_DEU_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_ESP_Patient-Card_ES | 1 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_FRA_Patient Reimbursement Form | 0 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_FRA_Patient Reimbursement Form Guidances | 0 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_FRA_Payment Reimbursement Notice | 10.3 |
| Subject information and informed consent form (for publication) | L3_TORL123-002_IRL_GP-Letter | 0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-517190-24-00_EN | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AUT_2024-517190-24-00_DE | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEL_2024-517190-24-00_DE | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEL_2024-517190-24-00_FR | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEL_2024-517190-24-00_NL | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZE_2024-517190-24-00_CZ | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DEU_2024-517190-24-00_DE | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRA_2024-517190-24-00_FR | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ITA_2024-517190-24-00_IT | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol-Synopsis_ESP_2024-517190-24-00_ES | 5 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-12 | Spain | Acceptable 2025-07-07
|
2025-07-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-31 | Spain | Acceptable 2025-10-09
|
2025-10-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-04 | Acceptable | 2026-01-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-04 | Acceptable | 2026-01-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-04 | Acceptable | 2025-12-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-04 | Acceptable | 2025-12-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-04 | Acceptable | 2026-01-08 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-04 | Acceptable | 2026-01-19 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-12-04 | Acceptable | 2026-01-25 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-05 | Spain | Acceptable | 2026-01-29 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-02-06 | Spain | Acceptable 2026-05-05
|
2026-05-05 |