Clinical trial • Phase III • Oncology
BELZUPACAP SAROTALOCAN for Primary indeterminate lesion | Small choroidal melanoma
Phase III trial of BELZUPACAP SAROTALOCAN for Primary indeterminate lesion | Small choroidal melanoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Primary indeterminate lesion | Small choroidal melanoma
- Trial Stage
- Phase III
- Drug Modality
- Other
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-11-2023
- First CTIS Authorization Date
- 20-05-2024
Trial design
Randomised, placebo (sham injection) to belzupacap sarotalocan solution for sham injection 0.0 mg/ml administered as a sham scs injection (no active drug).-controlled Phase III trial across 28 sites in Sweden, Greece, Ireland and others.
- Randomised
- Yes
- Comparator
- Placebo (Sham injection) to Belzupacap Sarotalocan solution for sham injection 0.0 mg/mL administered as a sham SCS injection (no active drug).
- Target Sample Size
- 125
- Trial Duration For Participant
- 455
Eligibility
Recruits 125 Vulnerable population flag selected. Study documents include country-specific subject information and informed consent forms and additional forms for pregnant participants / pregnant partners (e.g. documents titled "Other Pregnant Partner", "Pregnancy ICF", "Pregnant Participant" in multiple country ICF sets). Informed consent is obtained from adult subjects using country-language ICFs; additional pregnancy-related information/consent materials and partner/pregnancy follow-up materials are provided where applicable. No paediatric/assent forms are listed..
- Vulnerable Population
- Vulnerable population flag selected. Study documents include country-specific subject information and informed consent forms and additional forms for pregnant participants / pregnant partners (e.g. documents titled "Other Pregnant Partner", "Pregnancy ICF", "Pregnant Participant" in multiple country ICF sets). Informed consent is obtained from adult subjects using country-language ICFs; additional pregnancy-related information/consent materials and partner/pregnancy follow-up materials are provided where applicable. No paediatric/assent forms are listed.
Inclusion criteria
- {"criterion_text":"- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) with documented early growth"}
- {"criterion_text":"- Have no evidence of metastatic disease confirmed by imaging"}
- {"criterion_text":"- Be treatment naïve for their IL/CM (Note: eligibility for subjects who have received treatment with photodynamic therapy >6 months prior to enrollment should be discussed with the medical monitor for approval prior to enrollment)."}
Exclusion criteria
- {"criterion_text":"- Any active eye infection or ocular disease in the study eye (other than IL/CM)"}
- {"criterion_text":"- Have known contraindications or sensitivities to the study drug or laser"}
- {"criterion_text":"- Have a history of any ocular surgery/procedure that could alter the SCS and affect the SC administration of study drug (e.g., scleral buckle, laser retinopexy, macular laser, or panretinal photocoagulation)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to reach Tumor Progression (at the Week 65 analysis).","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Time to reach the Composite Endpoint (at the Week 65 analysis). • Tumor progression or visual acuity failure","definition_or_measurement_approach":"Composite defined as tumor progression or visual acuity failure (as stated in the endpoint text)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 125
- Recruitment Window Months
- 33
- Consent Approach
- Informed consent obtained from adult participants using country-specific main ICFs (adult ICFs available in multiple languages per country). Additional consent/information documents exist for pregnant participants and pregnant partners. Consent appears to be provided by the adult subject (no paediatric assent forms listed). Country-language ICFs include English, Spanish, French, German, Dutch, Italian, Czech, Danish and others as shown by document titles.
Methods
- Use of country-specific recruitment brochures (K1) and posters (K2) targeted to patients with primary indeterminate lesions or small choroidal melanoma (documents present for multiple countries).
- Site-driven recruitment procedures described in country-specific Recruitment Procedure Description (K1) documents.
- Use of subject information materials and country-specific ICFs to support recruitment at sites (multiple language ICFs available).
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 142
Sweden
- Earliest CTIS Part Ii Submission Date
- 17-03-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Processing Time Days
- 191
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- St Erik Eye Hospital
- Department Name
- 75201: Ocular Oncology Service
- Principal Investigator Name
- Maria Fili
- Principal Investigator Email
- maria.fili@regionstockholm.se
- Contact Person Name
- Maria Fili
- Contact Person Email
- maria.fili@regionstockholm.se
Greece
- Earliest CTIS Part Ii Submission Date
- 29-12-2023
- Latest Decision Or Authorization Date
- 07-07-2025
- Processing Time Days
- 556
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Mitera S.A.
- Department Name
- 30001: Ocular Oncology Adult and Children Department
- Principal Investigator Name
- Maria Pefkianaki
- Principal Investigator Email
- maria.pefkianaki@gmail.com
- Contact Person Name
- Maria Pefkianaki
- Contact Person Email
- maria.pefkianaki@gmail.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 30-06-2025
- Processing Time Days
- 490
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Royal Victoria Eye And Ear Hospital
- Department Name
- 37201: Ophthalmology
- Principal Investigator Name
- Noel Horgan
- Principal Investigator Email
- n.horgan@svhg.ie
- Contact Person Name
- Noel Horgan
- Contact Person Email
- n.horgan@svhg.ie
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 735
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- 20303:Ocni klinika
- Principal Investigator Name
- Lenka Hecova
- Principal Investigator Email
- hecoval@fnplzen.cz
- Contact Person Name
- Lenka Hecova
- Contact Person Email
- hecoval@fnplzen.cz
- Site Name
- Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
- Department Name
- 20304:Ocni klinika
- Principal Investigator Name
- Zuzana Hradcova
- Principal Investigator Email
- zuzana.hradcova@uvn.cz
- Contact Person Name
- Zuzana Hradcova
- Contact Person Email
- zuzana.hradcova@uvn.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- 20301:Ocni oddeleni
- Principal Investigator Name
- Katerina Myslik Manethova
- Principal Investigator Email
- katerina.manethova@ftn.cz
- Contact Person Name
- Katerina Myslik Manethova
- Contact Person Email
- katerina.manethova@ftn.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 17-03-2024
- Latest Decision Or Authorization Date
- 21-03-2026
- Processing Time Days
- 734
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Bellvitge University Hospital
- Department Name
- 72403: Oftalmología
- Principal Investigator Name
- José María Caminal Mitjana
- Principal Investigator Email
- jmcaminal@bellvitgehospital.cat
- Contact Person Name
- José María Caminal Mitjana
- Contact Person Email
- jmcaminal@bellvitgehospital.cat
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- 72402: Oftalmología
- Principal Investigator Name
- Maria José Blanco Teijeiro
- Principal Investigator Email
- maria.jose.blanco.teijeiro@sergas.es
- Contact Person Name
- Maria José Blanco Teijeiro
- Contact Person Email
- maria.jose.blanco.teijeiro@sergas.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- 72404: Oftalmología
- Principal Investigator Name
- Maria Isabel Relimpio Lopez
- Principal Investigator Email
- irelimpio@gmail.com
- Contact Person Name
- Maria Isabel Relimpio Lopez
- Contact Person Email
- irelimpio@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- 72401: Oftalmología
- Principal Investigator Name
- Rafael Martínez
- Principal Investigator Email
- rafael.martinez-costa@uv.es
- Contact Person Name
- Rafael Martínez
- Contact Person Email
- rafael.martinez-costa@uv.es
France
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 731
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Hopital Pasteur
- Principal Investigator Name
- Sacha Nahon-Estève
- Principal Investigator Email
- nahon-esteve.s@chu-nice.fr
- Contact Person Name
- Sacha Nahon-Estève
- Contact Person Email
- nahon-esteve.s@chu-nice.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Ophthalmology Department
- Principal Investigator Name
- Thibaud MATHIS
- Principal Investigator Email
- thibaud.mathis@chu-lyon.fr
- Contact Person Name
- Thibaud MATHIS
- Contact Person Email
- thibaud.mathis@chu-lyon.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-03-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 733
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Ophthalmology
- Principal Investigator Name
- Paulina Bartoszek
- Principal Investigator Email
- paulina.bartoszek@saintluc.uclouvain.be
- Contact Person Name
- Paulina Bartoszek
- Contact Person Email
- paulina.bartoszek@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Ophthalmology
- Principal Investigator Name
- Joachim Van Calster
- Principal Investigator Email
- joachim.vancalster@uzleuven.be
- Contact Person Name
- Joachim Van Calster
- Contact Person Email
- joachim.vancalster@uzleuven.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 731
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Rigshospitalet
- Department Name
- 20801: Copenhagen Neuromuscular Center
- Principal Investigator Name
- Jens Kiilgaard
- Principal Investigator Email
- jens.folke.kiilgaard@regionh.dk
- Contact Person Name
- Jens Kiilgaard
- Contact Person Email
- jens.folke.kiilgaard@regionh.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 26-01-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 787
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Zentrum für Augenheilkunde
- Principal Investigator Name
- Konrad Reinhard Koch
- Principal Investigator Email
- konrad.koch@uk-koeln.de
- Contact Person Name
- Konrad Reinhard Koch
- Contact Person Email
- konrad.koch@uk-koeln.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- 27606:Augenheilkunde
- Principal Investigator Name
- Christos Skevas
- Principal Investigator Email
- c.skevas@uke.de
- Contact Person Name
- Christos Skevas
- Contact Person Email
- c.skevas@uke.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- 27602:Klinik für Augenheilkunde
- Principal Investigator Name
- Antonia M Joussen
- Principal Investigator Email
- antonia.joussen@charite.de
- Contact Person Name
- Antonia M Joussen
- Contact Person Email
- antonia.joussen@charite.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein
- Department Name
- 27601:Klinik für Augenheilkunde
- Principal Investigator Name
- Svenja Sonntag
- Principal Investigator Email
- svenja.sonntag@uksh.de
- Contact Person Name
- Svenja Sonntag
- Contact Person Email
- svenja.sonntag@uksh.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- 27604: Augenklinik und Poliklinik
- Principal Investigator Name
- Paul Foerster
- Principal Investigator Email
- paul.foerster@med.uni-muenchen.de
- Contact Person Name
- Paul Foerster
- Contact Person Email
- paul.foerster@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- 27605:Augenklinik
- Principal Investigator Name
- Daniela Suesskind
- Principal Investigator Email
- daniela.suesskind@med.uni-tuebingen.de
- Contact Person Name
- Daniela Suesskind
- Contact Person Email
- daniela.suesskind@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- 27608: Zentrum für Augenheilkunde
- Principal Investigator Name
- Nikolaos Bechrakis
- Principal Investigator Email
- nikolaos.bechrakis@uk-essen.de
- Contact Person Name
- Nikolaos Bechrakis
- Contact Person Email
- nikolaos.bechrakis@uk-essen.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 732
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- 52802: ophthalmology
- Principal Investigator Name
- Emine Kiliç-Ciğirci
- Principal Investigator Email
- e.kilic@erasmusmc.nl
- Contact Person Name
- Emine Kiliç-Ciğirci
- Contact Person Email
- e.kilic@erasmusmc.nl
- Site Name
- Academisch Ziekenhuis Leiden
- Department Name
- 52801: ophthalmology
- Principal Investigator Name
- Khanh Vu
- Principal Investigator Email
- t.h.k.vu@lumc.nl
- Contact Person Name
- Khanh Vu
- Contact Person Email
- t.h.k.vu@lumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 775
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oncologia Oculare
- Principal Investigator Name
- Monica Maria Pagliara
- Principal Investigator Email
- monicamaria.pagliara@policlinicogemelli.it
- Contact Person Name
- Monica Maria Pagliara
- Contact Person Email
- monicamaria.pagliara@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- S.C. Chirurgia Oncologica oculare
- Principal Investigator Name
- Martina Angi
- Principal Investigator Email
- martina.angi@istitutotumori.mi.it
- Contact Person Name
- Martina Angi
- Contact Person Email
- martina.angi@istitutotumori.mi.it
- Site Name
- Careggi University Hospital
- Department Name
- Oncologia Oculare Unit
- Principal Investigator Name
- Cinzia Mazzini
- Principal Investigator Email
- cinzia.mazzini@unifi.it
- Contact Person Name
- Cinzia Mazzini
- Contact Person Email
- cinzia.mazzini@unifi.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- U.O. Clinica Oculistica
- Principal Investigator Name
- Marco Pellegrini
- Principal Investigator Email
- marco.pellegrini@asst-fbf-sacco.it
- Contact Person Name
- Marco Pellegrini
- Contact Person Email
- marco.pellegrini@asst-fbf-sacco.it
Austria
- Earliest CTIS Part Ii Submission Date
- 17-03-2024
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 779
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Medical University Of Graz
- Department Name
- 04002: Universitats-Augenklinik
- Principal Investigator Name
- Thomas Georgi
- Principal Investigator Email
- thomas.georgi@medunigraz.at
- Contact Person Name
- Thomas Georgi
- Contact Person Email
- thomas.georgi@medunigraz.at
- Site Name
- Medical University Of Vienna
- Department Name
- 04001: Augenheilkunde und Optometrie
- Principal Investigator Name
- Roman Dunavölgyi
- Principal Investigator Email
- roman.dunavoelgyi@meduniwien.ac.at
- Contact Person Name
- Roman Dunavölgyi
- Contact Person Email
- roman.dunavoelgyi@meduniwien.ac.at
Sponsor
Primary sponsor
- Full Name
- Aura Biosciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Multiple clinical development responsibilities (sponsorDuties codes listed in CTIS record)
- Name
- Longboat Clinical Limited
- Responsibilities
- Document repository, training and anonymized prescreen navigator
- Name
- CIRION Biopharma Research Inc.
- Responsibilities
- Local clinical operations (sponsorDuties code listed)
- Name
- Voiant LLC
- Responsibilities
- Central Imaging and Site Staff Training and Certification
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 3, 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursements","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Document repository, training and anonymized prescreen navigator","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"B2S Life Sciences LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"CIRION Biopharma Research Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"Central Imaging and Site Staff Training and Certification","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"Trial Drug Mgtn, Device Mgtn, Packaging/Labeling, Shipping Clinical Supplies, Destruction of IMP at EOS; Temp Excursions Triage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eurofins Central Laboratory LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Visual Acuity certification for site staff and training for CRAs","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"QP release, Batch Release, Storage and distribution, Packaging and labelling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1, 2, 4, 5, 6, 9, 10, 12, 13, 14 (multiple clinical development responsibilities recorded)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BELZUPACAP SAROTALOCAN
- Active Substance
- BELZUPACAP SAROTALOCAN
- Modality
- Other
- Routes Of Administration
- SUPRACHOROIDAL
- Route
- SUPRACHOROIDAL
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- Max daily 80 µg; Max total 240 µg
- Investigational Product Name
- Placebo (Sham injection) to Belzupacap Sarotalocan solution for sham injection 0.0 mg/mL
- Modality
- Other
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)