HLX3902 / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Castration-Resistant Prostate Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

Shanghai Henlius Biotech has received approval from China’s National Medical Products Administration for a phase 1 clinical trial of HLX3902, a trispecific antibody injection targeting metastatic castration-resistant prostate cancer and other advanced solid tumors. (TipRanks) - "The candidate has also cleared ethics review and been acknowledged by Australia’s Therapeutic Goods Administration, underscoring Henlius’s intention to develop HLX3902 on a global path."

New P1 trial • Castration-Resistant Prostate Cancer • Solid Tumor

Henlius Wins Australian Nod to Start First-in-Class Trispecific Antibody Trial for Advanced Prostate Cancer (TipRanks) - "Henlius secured Australian approval to start a phase 1 trial of HLX3902, a trispecific STEAP1×CD3×CD28 antibody for metastatic castration-resistant prostate cancer and other advanced solid tumors...The candidate is designed to redirect and amplify cytotoxic T-cell activity against STEAP1-expressing tumors, and preclinical data suggest promising anti-tumor efficacy and safety, positioning Henlius at the forefront of a modality for which no STEAP1-

New P1 trial • Castration-Resistant Prostate Cancer

Henlius to Showcase Seven FIC/BIC Innovative Assets at AACR 2026, Highlighting Accelerated Early-Stage Innovation (Henlius Press Release) - "These include HLX43 (PD-L1 ADC), HLX316 (B7-H3×sialidase fusion protein), HLX3902 (STEAP1×CD3×CD28 trispecific T-cell engager)..."

Preclinical • Prostate Cancer

A novel anti-CD3×CD28×STEAP1 tri-specific T-cell engager with enhanced and durable antitumor responses in prostate cancer (AACR 2026) - "HLX3902 demonstrated enhanced T cell function and sustained in vitro cytotoxicity compared with bispecific TCEs and their combinations, showing superior T-cell proliferation and enhanced expansion of memory T cells. Furthermore, Anti-CD3×CD28×STEAP1 TCE demonstrated superior and sustained antitumor activity in both humanized PBMC/cell line-derived xenograft and PDX models at a single 0.01 mg/kg dose, with increased T-cell infiltration, activation, and persistent intratumoral CD8+ T cells resulting from CD28 co-stimulation compared to AMG509... We developed a novel tri-specific TCE with optimized CD3 and CD28 signaling, effectively co-engages T cells and STEAP1-expressing tumor cells. It elicits potent, target-dependent T-cell activation and cytotoxicity, The incorporation of CD28 signaling significantly improved T-cell persistence and sustained functional activity against repeated antigen challenges in vitro and in vivo. It was well tolerated in cynomolgus..."

Trispecific • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • STEAP1

A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

First-in-human • New P1 trial • Castration-Resistant Prostate Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor