MHB009C / Minghui Pharma - LARVOL DELTA

A Study of MHB009C in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

Preclinical development of MHB009C: A novel anti-B7-H4 ADC with a potent topoisomerase I inhibitor (AACR 2025) - "It exhibited potent cytotoxicity in B7-H4-positive breast cancer cell lines and showed significant antitumor activity in an MX-1 breast cancer xenograft model. GLP study in monkeys revealed a favorable safety profile with no off-target toxicities, and the highest non-severely toxic dose (HNSTD) was determined to be 30 mg/kg Q3W, the maximum dose tested.In conclusion, MHB009C demonstrated potent anti-tumor activity both in vitro and in vivo, along with a favorable safety profile, supporting further clinical development."

ADC • Preclinical • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

A Study of MHB009C in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

First-in-human • New P1/2 trial • Solid Tumor

11 Class 1 innovative drugs were approved for clinical trials in China for the first time!… [Google translation] (Sina Corp) - "The Class 1 new drug MHB009C for injection, which was applied by Minghui Pharmaceutical, has been approved for clinical trials and is intended to be developed for the treatment of patients with advanced malignant solid tumors. The specific mechanism of action of this product has not yet been found in public information, but the acceptance number shows that this is a new biological product....SIM0505, a Class 1 new drug for injection filed by Innovent, a subsidiary of Innovent, has been approved for clinical trials and is intended to be used to treat advanced solid tumors."

New trial • Solid Tumor