Clinical trial • Phase I/II • Oncology
MCLA-129 for Non-small cell lung cancer | Solid tumours
Phase I/II trial of MCLA-129 for Non-small cell lung cancer | Solid tumours.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Solid tumours
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 17-09-2024
- First CTIS Authorization Date
- 14-10-2024
Trial design
MCLA-129 monotherapy and MCLA-129 in combination with chemotherapy (paclitaxel, docetaxel, carboplatin) and osimertinib; no doses or schedules specified in the available record.-controlled, adaptive Phase I/II trial across 38 sites in Belgium, Germany, Italy and others.
- Comparator
- MCLA-129 monotherapy and MCLA-129 in combination with chemotherapy (paclitaxel, docetaxel, carboplatin) and osimertinib; no doses or schedules specified in the available record.
- Adaptive
- True, dose-escalation and expansion study design is specified; specific escalation rules, interim analyses or stopping rules are not provided in the available record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 49
Eligibility
Recruits 49 Vulnerable population selected. Consent requirements: 'Signed informed consent form (ICF) before initiation of any study procedures'. Participants must be age ≥18 years at signing of the ICF. No assent procedures or minor consent arrangements are described in the available record..
- Pregnancy Exclusion
- Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-129.
- Vulnerable Population
- Vulnerable population selected. Consent requirements: 'Signed informed consent form (ICF) before initiation of any study procedures'. Participants must be age ≥18 years at signing of the ICF. No assent procedures or minor consent arrangements are described in the available record.
Inclusion criteria
- {"criterion_text":"- Signed informed consent form (ICF) before initiation of any study procedures\n- Age ≥18 years at signing of ICF\n- Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n- Adequate cardiac and organ function\n- Life expectancy ≥ 12 weeks, as per Investigator."}
Exclusion criteria
- {"criterion_text":"- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry\n- History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents\n- Uncontrolled hypertension with appropriate treatment, or unstable angina\n- History of clinically significant cardiovascular disease\n- History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for at least 3 years\n- Patients with a history of interstitial lung disease (ILD)\n- Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-129."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Frequency and severity of adverse events, serious adverse events, treatment discontinuations and modifications","definition_or_measurement_approach":""}
- {"endpoint_text":"- Pharmacokinetic parameters (CEOI, Cmax, C0h, AUC, CL, Vss, tmax and t1/2,) and population pharmacokinetics","definition_or_measurement_approach":"PK parameters listed explicitly: CEOI, Cmax, C0h, AUC, CL, Vss, tmax and t1/2 and population PK analyses."}
- {"endpoint_text":"- Progression-Free Survival (PFS) and Duration of Response (DOR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 49
- Recruitment Window Months
- 42
- Consent Approach
- Signed informed consent form (ICF) required before initiation of any study procedures. Participants must be age ≥18 years at signing of the ICF. ICF documents available in multiple languages (English, French, Dutch indicated in available ICF documents). No assent procedures described.
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 238
Belgium
- Latest Decision Or Authorization Date
- 18-10-2024
- Number Of Sites
- 2
- Number Of Participants
- 23
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Medical oncology department
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Institut Jules Bordet
- Department Name
- Medical oncology department
- Principal Investigator Name
- Mariana Brandao
- Principal Investigator Email
- Mariana.Brandao@bordet.be
- Contact Person Name
- Mariana Brandao
- Contact Person Email
- Mariana.Brandao@bordet.be
Germany
- Latest Decision Or Authorization Date
- 21-10-2024
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Institut für Klinisch-Onkologische Forschung (IKF)
- Principal Investigator Name
- Thorsten Oliver Goetze
- Principal Investigator Email
- Goetze.thorsten@khnw.de
- Contact Person Name
- Thorsten Oliver Goetze
- Contact Person Email
- Goetze.thorsten@khnw.de
- Site Name
- Sana Klinikum Offenbach GmbH
- Department Name
- Medizinische Klinik IV, Hämatologie und internistische Onkologie
- Principal Investigator Name
- Thomas Wehler
- Principal Investigator Email
- thomas.wehler@sana.de
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- thomas.wehler@sana.de
Italy
- Latest Decision Or Authorization Date
- 03-12-2024
- Number Of Sites
- 8
- Number Of Participants
- 34
Sites
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Stefano Pepe
- Principal Investigator Email
- stefano.pepe@sangiovannieruggi.it
- Contact Person Name
- Stefano Pepe
- Contact Person Email
- stefano.pepe@sangiovannieruggi.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Medical Oncology
- Principal Investigator Name
- Federico Cappuzzo
- Principal Investigator Email
- federico.cappuzzo@ifo.it
- Contact Person Name
- Federico Cappuzzo
- Contact Person Email
- federico.cappuzzo@ifo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Oncology
- Principal Investigator Name
- Salvatore Grisanti
- Principal Investigator Email
- salvatore.grisanti@unibs.it
- Contact Person Name
- Salvatore Grisanti
- Contact Person Email
- salvatore.grisanti@unibs.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Pulmonary Oncology
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andrea Ardizzoni
- Principal Investigator Email
- andrea.ardizzoni@aosp.bo.it
- Contact Person Name
- Andrea Ardizzoni
- Contact Person Email
- andrea.ardizzoni@aosp.bo.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Davide Melisi
- Principal Investigator Email
- davide.melisi@univr.it
- Contact Person Name
- Davide Melisi
- Contact Person Email
- davide.melisi@univr.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Hematology, Oncology and Molecular Medicine
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@ospedaleniguarda.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Filippo De Braud
- Principal Investigator Email
- Filippo.DeBraud@istitutotumori.mi.it
- Contact Person Name
- Filippo De Braud
- Contact Person Email
- Filippo.DeBraud@istitutotumori.mi.it
Spain
- Latest Decision Or Authorization Date
- 21-10-2024
- Number Of Sites
- 13
- Number Of Participants
- 120
Sites
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Fabricio Racca Bussano
- Principal Investigator Email
- nvelazquez@i-crom.net
- Contact Person Name
- Fabricio Racca Bussano
- Contact Person Email
- nvelazquez@i-crom.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology
- Principal Investigator Name
- Georgia Anguera Palacios
- Principal Investigator Email
- ganguera@santpau.cat
- Contact Person Name
- Georgia Anguera Palacios
- Contact Person Email
- ganguera@santpau.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Principal Investigator Name
- Miguel Fernandez de Sanmamed Gutierrez
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez de Sanmamed Gutierrez
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Medical Oncology
- Principal Investigator Name
- Tatiana Hernandez Guerrero
- Principal Investigator Email
- tatiana.hernandez@start-barcelona.com
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Medical Oncology
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- lpazares@hotmail.com
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Miguel Fernandez de Sanmamed Gutierrez
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez de Sanmamed Gutierrez
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ignacio Gil Bazo
- Principal Investigator Email
- igbazo@unav.es
- Contact Person Name
- Ignacio Gil Bazo
- Contact Person Email
- igbazo@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Victor Moreno Garcia
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Medical Oncology
- Principal Investigator Name
- Oscar José Juan Vidal
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar José Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Calles Blanco
- Principal Investigator Email
- antonio.calles@live.com
- Contact Person Name
- Antonio Calles Blanco
- Contact Person Email
- antonio.calles@live.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhebron.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhebron.net
Netherlands
- Latest Decision Or Authorization Date
- 14-10-2024
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Netherlands Cancer Institute
- Department Name
- Pulmonology
- Principal Investigator Name
- Gerrina Ruiter
- Principal Investigator Email
- g.ruiter@nki.nl
- Contact Person Name
- Gerrina Ruiter
- Contact Person Email
- g.ruiter@nki.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmonary medicine
- Principal Investigator Name
- Anne-Marie Dingemans
- Principal Investigator Email
- a.dingemans@erasmusmc.nl
- Contact Person Name
- Anne-Marie Dingemans
- Contact Person Email
- a.dingemans@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pulmonology
- Principal Investigator Name
- Anthonie van der Wekken
- Principal Investigator Email
- a.j.van.der.wekken@umcg.nl
- Contact Person Name
- Anthonie van der Wekken
- Contact Person Email
- a.j.van.der.wekken@umcg.nl
France
- Latest Decision Or Authorization Date
- 22-01-2025
- Number Of Sites
- 10
- Number Of Participants
- 46
Sites
- Site Name
- Direction Centrale Du Service De Sante Des Armees
- Department Name
- Oncology / clinical research Unit
- Principal Investigator Name
- Hugo Picchi
- Principal Investigator Email
- picchi.hugo90@gmail.com
- Contact Person Name
- Hugo Picchi
- Contact Person Email
- picchi.hugo90@gmail.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumology Department Chest Oncologic Unit
- Principal Investigator Name
- Marie WISLEZ
- Principal Investigator Email
- marie.wislez@aphp.fr
- Contact Person Name
- Marie WISLEZ
- Contact Person Email
- marie.wislez@aphp.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Department of medical oncology
- Principal Investigator Name
- Cécile VICIER
- Principal Investigator Email
- vicierc@ipc.unicancer.fr
- Contact Person Name
- Cécile VICIER
- Contact Person Email
- vicierc@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Regional Cancer Center
- Principal Investigator Name
- Nicolas ISAMBERT
- Principal Investigator Email
- Nicolas.isambert@chu-poitiers.fr
- Contact Person Name
- Nicolas ISAMBERT
- Contact Person Email
- Nicolas.isambert@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Medical Oncology Department
- 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
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pneumology department
- Principal Investigator Name
- Michaël Duruisseaux
- Principal Investigator Email
- Michael.duruisseaux@chu-lyon.fr
- Contact Person Name
- Michaël Duruisseaux
- Contact Person Email
- Michael.duruisseaux@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris (46 Rue Henri Huchard)
- Department Name
- Chest Oncologic Departement
- Principal Investigator Name
- Gérard ZALCMAN
- Principal Investigator Email
- Gerard.zalcman@aphp.fr
- Contact Person Name
- Gérard ZALCMAN
- Contact Person Email
- Gerard.zalcman@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pulmonology and Thoracic Oncology department
- Principal Investigator Name
- Alexis CORTOT
- Principal Investigator Email
- alexis.cortot@chu-lille.fr
- Contact Person Name
- Alexis CORTOT
- Contact Person Email
- alexis.cortot@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Chest Oncologic Unit
- Principal Investigator Name
- Elvire PONS-TOSTIVINT
- Principal Investigator Email
- elvire.pons@chu-nantes.fr
- Contact Person Name
- Elvire PONS-TOSTIVINT
- Contact Person Email
- elvire.pons@chu-nantes.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumology department
- Principal Investigator Name
- Isabelle MONNET
- Principal Investigator Email
- Isabelle.monnet@chicreteil.fr
- Contact Person Name
- Isabelle MONNET
- Contact Person Email
- Isabelle.monnet@chicreteil.fr
Sponsor
Primary sponsor
- Full Name
- Merus B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- Q Squared Solutions Limited
- Responsibilities
- Central Laboratory for study lab kits, lab procedure manual and receipt of samples and logistics
- Name
- Almac Clinical Services Limited
- Responsibilities
- IXRS (Interactive Voice/Web Response System)
- Name
- BioClinica GmbH
- Responsibilities
- Medical image analysis/ review only for responder patients
- Name
- Fortrea Development Limited
- Responsibilities
- Monitoring, Regulatory Expertise, Investigator Recruitment, Safety Reporting, Statistical Analysis, Project Management
Third parties
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Laboratory for study lab kits, lab procedure manual and receipt of samples and logistics","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IXRS (Interactive Voice/Web Response System)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioClinica GmbH","duties_or_roles":"Medical image analysis/ review only for responder patients","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"Monitoring, Regulatory Expertise, Investigator Recruitment, Safety Reporting, Statistical Analysis, Project Management","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MCLA-129
- Active Substance
- MCLA-129
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus 1
- Investigational Product Name
- DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- OSIMERTINIB
- Active Substance
- OSIMERTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus 2
- Combination Treatment
- Yes
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