Clinical trial • Phase I/II • Oncology
TECAGINLIMAB for Malignant solid tumour|Melanoma|Non-small cell lung cancer|Head and neck squamous cell carcinoma|Pancreatic ductal adenocarcinoma|Colorectal cancer
Phase I/II trial of TECAGINLIMAB for Malignant solid tumour|Melanoma|Non-small cell lung cancer|Head and neck squamous cell carcinoma|Pancreatic ductal ad…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Malignant solid tumour|Melanoma|Non-small cell lung cancer|Head and neck squamous cell carcinoma|Pancreatic ductal adenocarcinoma|Colorectal cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody|Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 10-04-2024
- First CTIS Authorization Date
- 19-06-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 27 sites in France, Italy, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation and safety run-in to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D); expansion cohorts (monotherapy and combination).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 593
Eligibility
Recruits 593 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Inclusion criteria
- {"criterion_text":"- • Monotherapy • Combination Therapy As defined in the protocol section Inclusion criteria"}
Exclusion criteria
- {"criterion_text":"- • Monotherapy • Combination Therapy As defined in the protocol section exclusion criteria"}
Endpoints
Primary endpoints
- {"endpoint_text":"- For dose escalation and safety run-in: • Dose-limiting toxicity (DLT)","definition_or_measurement_approach":"No further definition provided in the CTIS record for DLT."}
- {"endpoint_text":"- For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment","definition_or_measurement_approach":"Measured as Objective Response Rate (ORR) per RECIST 1.1 by investigator assessment."}
Secondary endpoints
- {"endpoint_text":"- Adverse events (AEs) and safety laboratory parameters","definition_or_measurement_approach":"Safety assessed by adverse events and safety laboratory parameters (no further detail in CTIS record)."}
- {"endpoint_text":"- ORR per RECIST 1.1 by investigator assessment (for dose escalation only)","definition_or_measurement_approach":"Objective Response Rate per RECIST 1.1 by investigator assessment (specified for dose escalation)."}
- {"endpoint_text":"- Duration of response (DOR) per RECIST 1.1 by investigator assessment","definition_or_measurement_approach":"Duration of response per RECIST 1.1 by investigator assessment."}
- {"endpoint_text":"- Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment","definition_or_measurement_approach":"Disease Control Rate per RECIST 1.1 by investigator assessment."}
- {"endpoint_text":"- Progression-free survival (PFS) per RECIST 1.1 by investigator assessment","definition_or_measurement_approach":"Progression-free survival per RECIST 1.1 by investigator assessment."}
- {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS) — no further definition provided in CTIS record."}
- {"endpoint_text":"- PK parameters and anti-drug antibodies (ADAs)","definition_or_measurement_approach":"Pharmacokinetic parameters and assessment of anti-drug antibodies (ADAs)."}
Recruitment
- Planned Sample Size
- 593
- Recruitment Window Months
- 89
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent form documents available in multiple languages (documents present for Italian, French, Spanish, Danish and English). Documents include adult-specific ICFs (e.g. 'Main Adult' titles). No vulnerable populations selected.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 270
France
- Latest Decision Or Authorization Date
- 27-01-2026
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- 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
- Site Name
- Institut Gustave Roussy
- Department Name
- Head and neck
- Principal Investigator Name
- Caroline Even
- Principal Investigator Email
- caroline.even@gustaveroussy.fr
- Contact Person Name
- Caroline Even
- Contact Person Email
- caroline.even@gustaveroussy.fr
Italy
- Latest Decision Or Authorization Date
- 28-01-2026
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncology
- Principal Investigator Name
- Lisa Francesca Linda Licitra
- Principal Investigator Email
- lisa.licitra@istitutotumori.mi.it
- Contact Person Name
- Lisa Francesca Linda Licitra
- Contact Person Email
- lisa.licitra@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliera Santa Croce E Carle
- Department Name
- Oncology
- Principal Investigator Name
- Giacomo Aimar
- Principal Investigator Email
- aimar.g@ospedale.cuneo.it
- Contact Person Name
- Giacomo Aimar
- Contact Person Email
- aimar.g@ospedale.cuneo.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncology
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@cancercenter.humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Oncology
- Principal Investigator Name
- Andrea Alberti
- Principal Investigator Email
- andrea.alberti@asst-spedalicivili.it
- Contact Person Name
- Andrea Alberti
- Contact Person Email
- andrea.alberti@asst-spedalicivili.it
Germany
- Latest Decision Or Authorization Date
- 04-05-2026
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Section of DermatoOncology, Department of Dermatology and National Center for Tumor diseases (NCT)
- Principal Investigator Name
- Jessica Hassel
- Principal Investigator Email
- jessica.hassel@med.uni-heidelberg.de
- Contact Person Name
- Jessica Hassel
- Contact Person Email
- jessica.hassel@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Department of Dermatology, Venerology and Allergology
- Principal Investigator Name
- Anja Gesierich
- Principal Investigator Email
- gesierich_a@ukw.de
- Contact Person Name
- Anja Gesierich
- Contact Person Email
- gesierich_a@ukw.de
Denmark
- Latest Decision Or Authorization Date
- 01-05-2026
- Number Of Sites
- 3
- Number Of Participants
- 35
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Oncology
- Principal Investigator Name
- Inna M. Chen
- Principal Investigator Email
- Inna.Chen@regionh.dk
- Contact Person Name
- Inna M. Chen
- Contact Person Email
- Inna.Chen@regionh.dk
- Site Name
- Rigshospitalet
- Department Name
- Oncology
- Principal Investigator Name
- Kristoffer Staal Rohrberg
- Principal Investigator Email
- kristoffer.staal.rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Christa Haugaard Nyhus
- Principal Investigator Email
- christa.haugaard.nyhus@rsyd.dk
- Contact Person Name
- Christa Haugaard Nyhus
- Contact Person Email
- christa.haugaard.nyhus@rsyd.dk
Spain
- Latest Decision Or Authorization Date
- 05-05-2026
- Number Of Sites
- 16
- Number Of Participants
- 189
Sites
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncología
- Principal Investigator Name
- Alfonso Gomez de Liaño
- Principal Investigator Email
- agomlis@gobiernodecanarias.org
- Contact Person Name
- Alfonso Gomez de Liaño
- Contact Person Email
- agomlis@gobiernodecanarias.org
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Principal Investigator Name
- Vanesa Varela-Pose
- Principal Investigator Email
- vanesa.varela.pose@sergas.es
- Contact Person Name
- Vanesa Varela-Pose
- Contact Person Email
- vanesa.varela.pose@sergas.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología
- Principal Investigator Name
- Zara Vidales Sepulveda
- Principal Investigator Email
- zaravidales@iconcologia.net
- Contact Person Name
- Zara Vidales Sepulveda
- Contact Person Email
- zaravidales@iconcologia.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Principal Investigator Name
- Juan Jose Soto Castillo
- Principal Investigator Email
- juanj.soto@startmadrid.com
- Contact Person Name
- Juan Jose Soto Castillo
- Contact Person Email
- juanj.soto@startmadrid.com
- Site Name
- Hospital Universitario 12 De Octubre
- Principal Investigator Name
- Luis Paz-Ares Rodríguez
- Principal Investigator Email
- lpazares@hotmail.com
- Contact Person Name
- Luis Paz-Ares Rodríguez
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology Department
- Principal Investigator Name
- Enriqueta Felip
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Immunology and Immunotherapy
- Principal Investigator Name
- Ignacio Javier Melero Bermejo
- Principal Investigator Email
- jmelero@unav.es
- Contact Person Name
- Ignacio Javier Melero Bermejo
- Contact Person Email
- jmelero@unav.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Principal Investigator Name
- Rosa María Álvarez Álvarez
- Principal Investigator Email
- rosa.alvarez.al@gmail.com
- Contact Person Name
- Rosa María Álvarez Álvarez
- Contact Person Email
- rosa.alvarez.al@gmail.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncología
- 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 Ramon Y Cajal
- Department Name
- Oncología
- Principal Investigator Name
- María Eugenia Olmedo García
- Principal Investigator Email
- maruolmedogarcia@hotmail.com
- Contact Person Name
- María Eugenia Olmedo García
- Contact Person Email
- maruolmedogarcia@hotmail.com
- Site Name
- Hospital Clinico San Carlos
- Principal Investigator Name
- Jorge Bartolomé Arcilla
- Principal Investigator Email
- jorgebart@msn.com
- Contact Person Name
- Jorge Bartolomé Arcilla
- Contact Person Email
- jorgebart@msn.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Victor Moreno García
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Principal Investigator Name
- Laura Medina
- Principal Investigator Email
- laura.medina@ibima.eu
- Contact Person Name
- Laura Medina
- Contact Person Email
- laura.medina@ibima.eu
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Principal Investigator Name
- Amparo Sanchez Gastaldo
- Principal Investigator Email
- asanchezgastaldo@gmail.com
- Contact Person Name
- Amparo Sanchez Gastaldo
- Contact Person Email
- asanchezgastaldo@gmail.com
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncology Service
- Principal Investigator Name
- Fernando Fabio Franco Pérez
- Principal Investigator Email
- ffranco@fundacionmdanderson.es
- Contact Person Name
- Fernando Fabio Franco Pérez
- Contact Person Email
- ffranco@fundacionmdanderson.es
- Site Name
- Hospital Clinico San Carlos (additional listing)
- Department Name
- Oncología
- Principal Investigator Name
- Ignacio Javier Melero Bermejo
- Principal Investigator Email
- jmelero@unav.es
- Contact Person Name
- Ignacio Javier Melero Bermejo
- Contact Person Email
- jmelero@unav.es
Sponsor
Primary sponsor
- Full Name
- Genmab A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Syneos Health Netherlands B.V.
- Name
- Fortrea Development Limited
- Responsibilities
- Management of Safety database and AE reporting
- Name
- Endpoint Clinical Inc.
- Responsibilities
- IVRS - treatemt randomisation
- Name
- Tigermed-Bdm Inc.
Third parties
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"Biomarker testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/review, Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"IMP concentration in plasma","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"Management of Safety database and AE reporting","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"immunophenotyping","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"BIOMARKER ANALYSIS (EXPANSION ONLY)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"local laboratories support services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"BioNTech SE","duties_or_roles":"BIOMARKER ANALYSIS (Germany ONLY)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Genmab US Inc.","duties_or_roles":"BIOMARKER ANALYSIS (EXPANSION ONLY)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ARENSIA Exploratory Medicine GmbH","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - treatemt randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"IMP concentration in plasma; detection and titration of anti-IMP antibodies in serum","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"BIOMARKER ANALYSIS (Germany ONLY)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Tigermed-Bdm Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"BIOMARKER ANALYSIS (EXPANSION ONLY)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Biomarker analysis","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- GEN1042 DP
- Active Substance
- TECAGINLIMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Not authorised
- First In Human
- Yes
- Investigational Product Name
- PEMBROLIZUMAB
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- PEMETREXED
- Active Substance
- PEMETREXED DISODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- Abraxane 5 mg/ml powder for dispersion for infusion.
- Active Substance
- PACLITAXEL ALBUMIN-BOUND
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- GEMCITABINE
- Active Substance
- GEMCITABINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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