HF50 / HighField Bio - LARVOL DELTA

Clinical pharmacology and immune pharmacodynamic profiling of HF50, a bifunctional T-cell engager incorporating TLR8/9 agonist activity, in patients with advanced solid tumors (ESMO 2026) - No abstract available

Clinical • Metastases • PK/PD data • Oncology • Solid Tumor • TLR8

Safety and Activity of HF50 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: HighField Biopharmaceuticals Corporation

New P1 trial • Oncology • Ovarian Cancer • Solid Tumor • HER-2

First-in-Human Evaluation of HF50, a Novel Liposomal HER2×CD3 T Cell Engager with TLR Agonist Payload, Demonstrates Tolerability and Early Clinical Response (SITC 2025) - P1 | "All participants gave informed consent before taking part.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • First-in-human • Late-breaking abstract • P1 data • Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • Solid Tumor • HER-2 • IFNG • IL10 • IL2 • IL4 • IL6

HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: HighField Biopharmaceuticals Corporation

New P1 trial • Oncology • Solid Tumor • CRP

HighField Biopharmaceuticals Granted Clearance of IND in China for Clinical Trial of its Unique TRAFsome T Cell Engager (HF50) To Treat Solid Tumor Cancers (Businesswire) - "HighField Biopharmaceuticals...announced today that the Center for Drug Evaluation of China’s National Medical Products Administration has granted clearance of the company’s Investigational New Drug (IND) application to begin a clinical trial of HF50 in patients with advanced solid tumor cancers....The Phase 1 open-label, dose escalation and dose expansion trial of HF50 will evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy in patients with advanced solid tumors. The trial is expect to begin in 1Q2025."

New P1 trial • Oncology • Solid Tumor