Clinical trial • Phase I • Oncology

PSMAxCD3 bispecific antibody for Prostate cancer | Castration-resistant prostate cancer

Phase I trial of PSMAxCD3 bispecific antibody for Prostate cancer | Castration-resistant prostate cancer. 44 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer | Castration-resistant prostate cancer
Trial Stage
Phase I
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
21-03-2024
First CTIS Authorization Date
12-04-2024

Trial design

Phase I trial across 2 sites in Germany.

Target Sample Size
44

Eligibility

Recruits 44 No vulnerable populations selected; no special consent or assent handling described..

Vulnerable Population
No vulnerable populations selected; no special consent or assent handling described.

Recruitment

Planned Sample Size
44
Recruitment Window Months
96

Geography

Total Number Of Sites
2
Total Number Of Participants
44

Germany

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
16-10-2025
Processing Time Days
575
Number Of Sites
2
Number Of Participants
44

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charité Benjamin Franklin Onkologische Studienzentrale
Contact Person Name
Sebastian Ochsenreither
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
KKE Translationale Immunologie Tübingen
Contact Person Name
Helmut Salih
Contact Person Email
kketi@med.uni-tuebingen.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Tuebingen AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
CC-1
Active Substance
PSMAxCD3 bispecific antibody
Modality
Bispecific antibody
First In Human
Yes

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