NCT05849298

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

An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium \[177Lu\] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans).

Detailed description

All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium \[68Ga\] gozetotide (hereinafter referred to as AAA517) or piflufolastat (18F) (also known as\[18F\]DCFPyL) PET/CT scan and conventional imaging (i.e., CT/MRI and bone scans). Piflufolastat- (18F) PET/CT scan will be performed in US only. The treatment duration will be up to 6 cycles of AAA617, treatment will be administered once every 6 weeks (duration of 1 cycle). Participants randomized to Arm B may continue to receive ARPI after second end of treatment (EOT2) outside the study protocol at the investigator's discretion and in accordance with local guidelines. The visit frequency will be every week 1 and week 4 of each of the 6 cycles and every 16 weeks thereafter (for both arms) until the first event of disease progression (RECIST 1.1) or until global end of study (EOS), whichever comes first. After cycle 1 the safety visit at week 4 is optional onsite and could be paired with efficacy assessments or handled remotely. No biomarker collections are expected after the last end of trial (EOT) visit is completed. The study duration will be approximately 36 months.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-03
• Primary completion: 2026-12-23
• Completion: 2026-12-23
• First posted: 2023-05-08
• Last updated: 2026-04-13

Locations

41 sites across 11 countries: United States, Brazil, Canada, Czechia, France, Germany, Italy, Poland, Singapore, South Korea, Spain

Regulatory

• FDA-regulated drug study