MHB048C / Minghui Pharma - LARVOL DELTA

A Study of MHB048C in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Initiation date: Oct 2025 ➔ Jan 2026

First-in-human • Trial initiation date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Preclinical development of MHB048C: A novel anti-PSMA ADC with a potent topoisomerase I inhibitor (AACR 2025) - "The FDA's approval of (177) Lu-PSMA-617 has validated PSMA as a therapeutic target for treating metastatic castration-resistant prostate cancer (mCRPC). In GLP monkey studies, MHB048C exhibited a favorable safety profile with no off-target toxicities. The highest non-severely toxic dose (HNSTD) was determined to be 45 mg/kg Q3W, the maximum dose tested.In conclusion, MHB048C demonstrated potent anti-tumor activity both in vitro and in vivo, along with a favorable safety profile, supporting advancement to clinical development."

ADC • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

A Study of MHB048C in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

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