177Lu-NYM032 / Norroy Biosci - LARVOL DELTA

Phase I/II trial of 177Lu-NYM032 for progressive metastatic castration-resistant prostate cancer. (ASCO 2025) - P1/2 | "Key eligibility criteria include confirmed PSMA-positive disease on 68Ga-NYM032 PET/CT, no discordant lesions on 18F-FDG PET/CT, prior progression following at least one potent androgen receptor (AR)-targeted therapy and docetaxel, or refusal/unfitness for chemotherapy. Preliminary results from this ongoing Phase I/II trial indicate that 177Lu-NYM032 is associated with manageable safety profile and demonstrates encouraging efficacy in patients with PSMA-positive mCRPC. These findings support the continued evaluation of 177Lu-NYM032, with further studies needed to define the optimal dose and confirm its clinical benefit. The trial is ongoing, and additional data will be critical in determining the therapeutic potential of this novel radiolabeled drug."

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

A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Norroy Bioscience Co., LTD | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Jun 2026 | Trial primary completion date: Nov 2024 ➔ Jun 2025

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

A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Norroy Bioscience Co., LTD

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