Phase 1 Study of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Start 30 Mar 2023 · Status Ongoing, recruiting · 3 EU/EEA countries · 13 sites · Protocol 20180146

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruiting

Participants planned 540

Countries 3

Sites 13

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Key facts

Sponsor: Amgen Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 30 Mar 2023 → ongoing
Decision date (initial): 2024-06-03
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2023-504361-23-00
EudraCT number: 2021-005052-11
WHO UTN: U1111-1303-4250
ClinicalTrials.gov: NCT04221542

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Version	Level	Code	Term	System organ class
21.1	LLT	10076506	Castration-resistant prostate cancer	10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation: Amgen Inc.
Address: 1 Amgen Center Drive
City: Thousand Oaks
Postcode: 91320-1799
Country: United States

Scientific contact point

Organisation: Amgen Inc.
Contact name: Medical Information

Public contact point

Organisation: Amgen Inc.
Contact name: Medical Information

Locations

3 EU/EEA countries · 13 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruiting	15	4
Portugal	Ongoing, recruiting	11	3
Spain	Ongoing, recruiting	35	6
Rest of world Australia, United States, Korea, Republic of, Japan, Taiwan, Switzerland, China	—	479	—

Investigational sites

Germany

4 sites · Ongoing, recruiting

Universitaetsklinikum Heidelberg AöR

NCT, Im Neuenheimer Feld 460, Neuenheim, Heidelberg

Universitaetsklinikum Essen AöR

Urology, Hufelandstrasse 55, Holsterhausen, Essen

Universitaet Muenster

Urology, Albert-Schweitzer-Campus 1, Sentrup, Muenster

Klinikum rechts der Isar der TU Muenchen AöR

Urology, Ismaninger Strasse 22, Au-Haidhausen, Munich

Portugal

3 sites · Ongoing, recruiting

START Lisbon, Hospital de Santa Maria, Centro Hospitalar Universitário de Lisboa Norte E.P.E.

Serviço de Oncologia Médica, Av. Prof. Egas Moniz, 1649-035, Lisbon

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.

Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto

Hospital Da Luz S.A.

Serviço de Oncologia, Avenida Lusiada 100, 1500-650, Lisbon

Spain

6 sites · Ongoing, recruiting

Hospital Universitario 12 De Octubre

Servicio de Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid

Hospital Universitari Vall D Hebron

Servicio de Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Hospital Clinic De Barcelona

Servicio de Oncologia Medica, Calle Villarroel 170, 08036, Barcelona

Clinica Universidad De Navarra

Servicio de Oncologia Medica, Avenue Pio XII 36, 31008, Pamplona

Hospital Clinico San Carlos

Servicio de Oncologia Medica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid