177Lu-NYM032 / Norroy Biosci - LARVOL DELTA

Norroy Bioscience has received approval from the National Medical Products Administration (NMPA) to start a Phase III clinical trial in China for 177Lu-NYM032, a prostate-specific membrane antigen (PSMA)-targeted small-molecule radioligand therapy. (World Pharmaceutical Frontiers) - "The study will assess the efficacy and safety of 177Lu-NYM032 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The randomised, open-label, multi-centre trial will be led by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and will take place at several centres in China. Initial clinical results for 177Lu-NYM032 from earlier Phase I/II studies suggested anti-tumour activity and a favourable safety profile. Further data are set to be presented at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM 26)...Additionally, the 68Ga/177Lu-NYM032 combination has secured investigational new drug (IND) clearance from the US Food and Drug Administration (FDA)."

IND • P1/2 data • Trial status • Castration-Resistant Prostate Cancer

Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Norroy Bioscience Co., LTD

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I dose-escalation results of 177Lu-NYM032 in patients with progressive metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2026) - P1/2 | "177Lu-NYM032 demonstrated a favorable safety profile and promising antitumor activity in patients with mCRPC, supporting further evaluation in Phase II studies."

Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

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