AAA802 / Novartis - LARVOL DELTA

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Novartis Pharmaceuticals | N=200 ➔ 70

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

NeoPSMA: Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (clinicaltrials.gov) - P1/2 | N=228 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | N=70 ➔ 200

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Jun 2027 ➔ Nov 2026

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Novartis Pharmaceuticals | N=200 ➔ 70 | Trial completion date: Dec 2027 ➔ Dec 2029

Enrollment change • Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Aug 2026 ➔ Jun 2027

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SatisfACtion: a phase 1/2 study of [225Ac]Ac-PSMA-R2 in patients with PSMA-positive metastatic castration-resistant prostate cancer with or without previous [177Lu]Lu-PSMA radioligand therapy (EANM 2024) - P1/2 | "Aim/Introduction: The PSMA-targeted radioligand therapy (RLT) [177Lu]Lu-PSMA-617 prolonged overall survival (OS) and radiographic progression-free survival (rPFS) when added to standard of care (SoC) in patients with metastatic castration-resistant prostate cancer (mCRPC) in the VISION study...The ongoing dose-escalation phase aims to evaluate the safety and tolerability of 225Ac-PSMA-R2 and determine the recommended dose for expansion (RDE)...Secondary endpoints in both phases include response rates, rPFS, PFS, OS, time to symptomatic skeletal event, PSA response, change in alkaline phosphatase and lactate dehydrogenase levels, pharmacokinetics and health-related quality of life. Exploratory endpoints include analysis of PSMA PET parameters and associations between molecular biomarkers and clinical efficacy."

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy. (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2026 ➔ Oct 2027

Metastases • Trial completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy. (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy. (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | N=100 ➔ 200

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy. (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

Metastases • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor