HDM2020 / Huadong Medicine - LARVOL DELTA

A phase I clinical study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HDM2020 (FGFR2b-ADC) in patients with advanced solid tumors (ESMO Asia 2025) - P1 | "All patients in this study will be required to provide tumor samples for FGFR2 IHC testing. Phase Ia will enroll patients with FGFR2 expression, defined by ≥1% tumor cells showing FGFR2 membrane protein expression intensity 1+, 2+, or 3+; In phase Ib, patients with positive FGFR2 expression will be enrolled, defined as ≥5% or 10% tumor cells showing FGFR2 membrane protein expression intensity 2+, or 3+."

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Cholangiocarcinoma • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor • FGF10 • FGFR2 • TOP1

A Study of HDM2020 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Solid Tumor

Preclinical development of HDM2020, a novel ADC targeting FGFR2b, in gastric cancer (GC) and squamous non-small cell lung cancer (sq-NSCLC) xenograft models (AACR 2025) - "FGFR2b expression were detected by IHC using various tumor paraffin sections. Combination of HDM2020 and avastin or paclitaxel demonstrated a synergistic effect in GC CDX model. Based on the clinical validation of FGFR2b in GC and signs of early preclinical activity in sq-NSCLC with significant unmet need, HDM2020 might has promising efficacy in these indications. HDM2020 is expected to enter clinical development in 2025.References:1: Seiya Sato, Shannon L Rhodes, et al. Fibroblast Growth Factor Receptor 2 Isoform IIIb (FGFR2b) Protein Overexpression and Biomarker Overlap in Patients With Advanced Gastric or Gastroesophageal Junction Cancer(GC/GEJC)."

IO biomarker • Preclinical • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BCOR • CLDN18 • FGFR2 • HER-2 • TP53