A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 3, 2024

Primary Completion Date

April 7, 2028

Study Completion Date

May 18, 2030

Conditions
Prostatic Neoplasm
Interventions
DRUG

AAA617

Administration intravenously once every 6 weeks (1 cycle) for 6 cycles

DRUG

AAA517

Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans

DRUG

Piflufolastat F 18

Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans

DRUG

ARPI

Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator

DRUG

ADT

as prescribed by the local investigator

OTHER

Best supportive care

as prescribed by the local investigator

Trial Locations (51)

10249

RECRUITING

Novartis Investigative Site, Berlin

13210

RECRUITING

Associated Med Professionals of NY, Syracuse

14021

RECRUITING

Novartis Investigative Site, Caen

16132

RECRUITING

Novartis Investigative Site, Genova

17403

RECRUITING

Wellspan York Hospital, York

18014

RECRUITING

Novartis Investigative Site, Granada

18057

RECRUITING

Novartis Investigative Site, Rostock

20141

RECRUITING

Novartis Investigative Site, Milan

28040

RECRUITING

Novartis Investigative Site, Madrid

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

29609

RECRUITING

Novartis Investigative Site, Brest

30607

RECRUITING

University Cancer and Blood Center LLC, Athens

32218

RECRUITING

University Of Florida, Jacksonville

36212

RECRUITING

Novartis Investigative Site, Vigo

36608

RECRUITING

Urology Associates of Mobile, Mobile

46010

RECRUITING

Novartis Investigative Site, Valencia

46254

RECRUITING

Urology Of Indiana, Indianapolis

49055

RECRUITING

Novartis Investigative Site, Angers

50323

RECRUITING

Unity Point Clinic, Des Moines

50937

RECRUITING

Novartis Investigative Site, Cologne

67200

RECRUITING

Novartis Investigative Site, Strasbourg

68130

RECRUITING

Urology Cancer Center PC, Omaha

75014

RECRUITING

Novartis Investigative Site, Paris

75231

RECRUITING

Urology Clinic of North Texas, Dallas

77030

RECRUITING

Houston Methodist Hospital, Houston

78229

RECRUITING

UT Health San Antonio Mays Cancer Center, San Antonio

79912

RECRUITING

Rio Grande Urology, El Paso

80131

RECRUITING

Novartis Investigative Site, Napoli

80218

RECRUITING

Rocky Mountain Cancer Centers, Denver

97477

RECRUITING

Oregon Urology Institute, Springfield

100028

RECRUITING

Novartis Investigative Site, Beijing

119228

RECRUITING

Novartis Investigative Site, Singapore

169608

RECRUITING

Novartis Investigative Site, Singapore

210029

RECRUITING

Novartis Investigative Site, Nanjing

75390-9034

RECRUITING

Univ of Texas Southwest Med Center, Dallas

01308-050

RECRUITING

Novartis Investigative Site, São Paulo

05652-000

RECRUITING

Novartis Investigative Site, São Paulo

B3H 2Y9

RECRUITING

Novartis Investigative Site, Halifax

M5G 2M9

RECRUITING

Novartis Investigative Site, Toronto

H2X 1R9

RECRUITING

Novartis Investigative Site, Montreal

H3T 1E2

RECRUITING

Novartis Investigative Site, Montreal

779 00

RECRUITING

Novartis Investigative Site, Olomouc

00128

RECRUITING

Novartis Investigative Site, Roma

6815 AD

RECRUITING

Novartis Investigative Site, Arnhem

25-640

RECRUITING

Novartis Investigative Site, Kielce

30-688

RECRUITING

Novartis Investigative Site, Krakow

03080

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

08907

RECRUITING

Novartis Investigative Site, L'Hospitalet de Llobregat

08221

WITHDRAWN

Novartis Investigative Site, Terrassa

08036

RECRUITING

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY