MRG006A / Lepu Biopharma - LARVOL DELTA

First-in-human phase I/II study of MRG006A, a first-in-class Glypican-3 (GPC3)–targeted antibody-drug conjugate (ADC), in patients (pts) with advanced hepatocellular carcinoma (HCC). (ASCO 2026) - P1/2 | "MRG006A demonstrated manageable safety and promising anti-tumor activity in heavily pretreated pts with GPC3-expressing advanced HCC. Our findings support the therapeutic potential of GPC3-directed ADC and merits further clinical investigations."

ADC • Clinical • First-in-human • IO biomarker • Metastases • P1/2 data • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

MRG006A, a novel glypican-3-targeting antibody-drug conjugate, demonstrated potent anti-tumor activity and good safety profile in preclinical studies (AACR 2024) - "Overall, the preclinical study results suggest that MRG006A is a feasible ADC drug candidate for treating GPC3-expressing cancers in clinical studies. MRG006A was aimed to submit IND in China and the U.S in 2024."

ADC • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (clinicaltrials.gov) - P1/2 | N=160 | Not yet recruiting | Sponsor: Lepu Biopharma Co., Ltd.

Checkpoint inhibition • New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Lepu Biopharma…announced today that it has successfully enrolled the first patient in the Phase II clinical study of its internally developed MRG006A, a next‑generation GPC3‑targeting Antibody‑Drug Conjugate (ADC) for advanced hepatocellular carcinoma (HCC) (flcube.com) - "The milestone marks MRG006A as the world’s first GPC3‑directed ADC to enter Phase II development."

Enrollment open • Hepatocellular Cancer

A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=343 | Recruiting | Sponsor: Shanghai Miracogen Inc.

New P1/2 trial • Solid Tumor

The first GPC3 ADC in China starts clinical trials [Google translation] (Sohu.com) - "On July 8, according to the official website of CDE, Lepu Biopharmaceuticals launched a Phase I/II clinical trial in China for MRG006A to evaluate its safety and tolerability in treating patients with advanced solid tumors (registration number: CTR20242454)."

Trial status • Oncology • Solid Tumor

The first GPC3 ADC in China has been submitted to clinical trials! [Google translation] (Sohu.com) - "On April 23, according to the CDE official website, Lepu Biotech’s first clinical application for MRG006A was accepted (acceptance number: CXSL2400256)....MRG006A is a new GPC3- targeted ADC drug developed by Lepu Biotechnology based on the Hi-TOPi technology platform..."

New trial • Oncology • Solid Tumor