HuA21 / HankeMab - LARVOL DELTA

Efficacy and safety of SHR-1811-based combination regimens in advanced HER2-overexpressing urothelial carcinoma: a single-center, multi-cohort, Exploratory research (ChiCTR) - P=N/A | N=45 | Sponsor: The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

New trial • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Safety Study of the Combination Regimen Based on HuA21 Monoclonal Antibody for the Treatment of Advanced HER2-overexpressing Solid Tumors (ChiCTR) - P=N/A | N=90 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

New trial • Breast Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

HuA21 combined with trastuzumab and chemotherapy in HER2-positive advanced gastric/GEJ adenocarcinoma: Phase Ib/II dose-escalation and expansion study (CTR20240640) (ESMO 2025) - P1/2 | "Methods Integrated Ib/II trial: Phase Ib (3+3 dose-escalation) evaluated HuA21 (20/30 mg/kg Q3W) + trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W), capecitabine (1000 mg/m 2 BID D1–14), and oxaliplatin (130 mg/m 2 Q3W). Conclusions HuA21 30 mg/kg + trastuzumab/CT showed numerically higher ORR (80.8%) and lower SAEs (6.7% vs 23.3%) versus 20 mg/kg, with PK supporting dose linearity. This regimen demonstrates promising efficacy/safety, establishing 30 mg/kg as RP3D for phase III evaluation in HER2-positive GC/GEJ."

Metastases • P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2

Anhui Anke Announces HuA21 Success in HER2‑Positive Gastric Cancer (flcube.com) - "The data were presented at the European Society for Medical Oncology (ESMO) 2025 Annual Congress. Clinical Highlights: Objective Response Rate (ORR); 80.8 % in the 30 mg/kg dose cohort; 76.7 % in the 20 mg/kg dose cohort; Safety Profile – Low incidence of adverse events; no clinically significant cardiotoxicity reported."

P1/2 data • Gastric Cancer