Clinical trial • Phase I • Oncology

GEN3018 for Relapsed or refractory acute myeloid leukemia | High-risk myelodysplastic syndrome

Phase I trial of GEN3018 for Relapsed or refractory acute myeloid leukemia | High-risk myelodysplastic syndrome. 40 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed or refractory acute myeloid leukemia | High-risk myelodysplastic syndrome
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
12-11-2025
First CTIS Authorization Date
16-01-2026

Trial design

Phase I trial across 6 sites in Denmark, Spain.

Target Sample Size
40

Eligibility

Recruits 40 Vulnerable population selected; no details on consent or assent handling provided in the record..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided in the record.

Recruitment

Planned Sample Size
40
Recruitment Window Months
20

Geography

Total Number Of Sites
6
Total Number Of Participants
40

Denmark

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
28
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Rigshospitalet
Department Name
Department of Haemotology
Principal Investigator Name
Claudia Schöllkopf
Principal Investigator Email
claudia.schoellkopf.01@regionh.dk
Contact Person Name
Claudia Schöllkopf
Site Name
Region Midtjylland
Department Name
Department of Hematology
Principal Investigator Name
Hans Beier Ommen
Principal Investigator Email
Hans.beier.ommen@rm.dk
Contact Person Name
Hans Beier Ommen
Contact Person Email
Hans.beier.ommen@rm.dk

Spain

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
22
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Haematology
Principal Investigator Name
Jordi Esteve Reyner
Principal Investigator Email
jesteve@clinic.cat
Contact Person Name
Jordi Esteve Reyner
Contact Person Email
jesteve@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Haematology
Principal Investigator Name
Olga Salamero Garcia
Principal Investigator Email
osalamero@vhio.net
Contact Person Name
Olga Salamero Garcia
Contact Person Email
osalamero@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Haematology
Principal Investigator Name
Pilar Martinez Sanchez
Contact Person Name
Pilar Martinez Sanchez
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Haematology
Principal Investigator Name
Pau Montesinos Fernandez
Principal Investigator Email
montesinos_pau@gva.es
Contact Person Name
Pau Montesinos Fernandez
Contact Person Email
montesinos_pau@gva.es

Sponsor

Primary sponsor

Full Name
Genmab A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
GEN3018
First In Human
Yes

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