What this study is
CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A*02:01 tissue marker and whose cancer is positive for MAGE-A4.
What's being tested
- CDR404
Intervention · BIOLOGICAL
IV infusions
Study details
- Official title
- Phase 1, First-in-Human Study to Assess the Safety, Tolerability and Anti-tumor Activity of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
- Sponsor
- CDR-Life AG
- Conditions
- Select Advanced Solid Tumors
- Enrolling
- 42 people
- Starts
- 2024-05-24
- Est. completion
- 2027-12-31
- Design
- Open-label, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Provision of written informed consent
- HLA-A*02:01 positive
- MAGE-A4 positive tumor
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
- Selected advanced solid tumors
- Relapsed from, refractory to, or intolerant of standard therapy
- Measurable disease per RECIST v1.1
- Adequate organ function
- If applicable, must agree to use highly effective contraception
You can't join if
- Symptomatic or untreated central nervous system metastasis
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Recent surgery
- Clinically significant cardiac disease
- Active infection requiring systemic antibiotic treatment
- Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
- Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
- Ongoing treatment with systemic steroids or other immunosuppressive therapies
- Significant secondary malignancy
- History of chronic or recurrent active autoimmune disease requiring treatment
- Uncontrolled intercurrent illness
- Pregnancy or lactation.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (20)
18 openProvidence Cancer Institute
Portland, Oregon, United States
- Providence Cancer Institute · ContactCanRsrchStudies@providence.org
- Contact+1-503-215-5763
- Rom Leidner, MD · Principal investigator
RecruitingPennsylvania Hospital
Philadelphia, Pennsylvania, United States
- Research Team · Contact+1-215-829-7089PAhemoncResearch@uphs.upenn.edu
- Mark Diamond, MD · Principal investigator
RecruitingUniversity of Miami
Miami, Florida, United States
WithdrawnUniversity of Michigan
Ann Arbor, Michigan, United States
Withdrawn
16 sites outside the US
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
- Amelie Lyssens · Contact+32 38215580studies.oncologie@uza.be
- Hans Prenen, MD · Principal investigator
RecruitingInstitut Jules Bordet
Brussels, Belgium
- Michele Schroeder · Contact+3225413833michele.schroeder@hubruxelles.be
- Nuria Kotecki, MD · Principal investigator
RecruitingCliniques Universitaires Saint-Luc, UCL Ouvain
Brussels, Belgium
- Jean-Pascal Machiels, MD · Contact+32 27645457jean-pascal.machiels@saintluc.uclouvain.be
- Jean-Pascal Machiels, MD · Principal investigator
RecruitingUniversitair Ziekenhuis Gent
Ghent, Belgium
- Tessa Lefebvre · Contact+32 38215580tessa.lefebvre@uzgent.be
- Sylvie Rottey, MD · Principal investigator
RecruitingRigshospitalet
Copenhagen, Denmark
- Phase 1 Unit · Contact+4535457966RH-FP-ThePhase1Unit@regionh.dk
- Iben Spanggaard, MD · Contact+45 35 45 35 45iben.spanggaard.01@regionh.dk
- Iben Spanggaard, MD · Principal investigator
RecruitingIstituto Clinico Humanitas
Milan, Italy
- Matteo Simonelli, MD · Contact+390282244559matteo.simonelli@cancercenter.humanitas.it
- Matteo Simonelli, MD · Principal investigator
RecruitingIsituto Europeo di Oncologia (IEO)
Milan, Italy
- Giuseppe Curigliano, MD · Contact+390257489960Giuseppe.curigliano@ieo.it
- Guiseppe Curigliano, MD · Principal investigator
RecruitingHospital Universitari Vall d'Hebron
Barcelona, Spain
- Montserrat Moreno · Contact+34 932543450 ext. 98814momoreno@vhio.net
- Alberto Hernando Calvo, MD · Principal investigator
RecruitingInstitut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
Barcelona, Spain
- Carmen Cuadra · Contact+34 932607294ccuadra@iconcologia.net
- Ramon Salazar MD Martin, MD · Principal investigator
RecruitingHospital 12 de Octubre
Madrid, Spain
- Sandra Tapial, Raquel Rodriguez, MariPaz Soriano, · Contact+34913908922unidadfase1.imas12@h12o.es
- Sandra de la Llave, Marta Gutierrez, Elisa Lorente, Lidia Silvo, Veronica Silva · Contact
- Guillermo de Velasco, MD · Principal investigator
RecruitingSTART Madrid
Madrid, Spain
- Ester Ordonez · Contact+34 917567800 ext. 4851ester.ordonez@startmadrid.com
- Sonia Puerta · Contactsonia.puerta@startmadrid.com
- Emiliano Calvo, MD · Principal investigator
RecruitingHospital Universitari i Politecnic La Fe
Valencia, Spain
- Lorena, Jimenez · Contact+34 618734852lorena.jimenez@iislafe.es
- Juan Genoves · Contactjuan.genoves@iislafe.es
- Guillermo Suay Montagud, MD · Principal investigator
RecruitingInstituto de Investigacion Sanitaria (INCLIVA)
Valencia, Spain
- Maribel Gomez · Contact+34 961973527iblasco@incliva.es
- Inma Blasco · Contact
- Desamparados Roda Perez, MD · Principal investigator
RecruitingRoyal Marsden Hospital
Sutton, London, United Kingdom
- Ekta Gosha · Contact+442089154409Ekta.Goshi@icr.ac.uk
- Alec MD Paschalis · Principal investigator
RecruitingThe Beatson West of Scotland Cancer Center
Glasgow, United Kingdom
- Jeff Evans · Contact(+44)1413017073j.evans@crukscotlandinstitute.ac.uk
- Jeff Evans · Principal investigator
RecruitingGuys and St Thomas' NHS Foundation Trust
London, United Kingdom
- Early Phase Research Team · Contact(+44)20 7188 8103gstt.earlyphaseresearchteam@nhs.net
- Rebecca Kristeleit · Principal investigator
Not yet recruiting
Study team
Sponsor
CDR-Life AG
Study ID CDR404-001
CONTACT
Dimitrios Chondros Chief Medical Officer, CDR-Life
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.