HLX3901 / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

Shanghai Henlius Biotech has begun dosing the first patient in a first-in-human phase 1 clinical trial of HLX3901, a tetra-specific antibody targeting DLL3 dual epitopes, CD3 and CD28, for advanced small cell lung cancer or neuroendocrine carcinoma in mainland China. (TipRanks)

Trial status • Neuroendocrine Carcinoma • Small Cell Lung Cancer

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC (clinicaltrials.gov) - P1 | N=138 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

In the field of prospective layout of early-stage pipeline, several new molecules have been approved for the clinical trials (The Manila Times) - "FXS0683, a next-generation Bcl-2 inhibitor, was approved for Phase I clinical trials in hematological malignancies. Innovative molecule including HLX97 (a KAT6A/B small molecule inhibitor) and HLX3901 (tetra specific antibody of DLL3×DLL3×CD3×CD28) were approved for clinical trials, widely covering refractory solid tumors such as breast cancer and small cell lung cancer."

New trial • Breast Cancer • Hematological Malignancies • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Shanghai Henlius Biotech, Inc…announced that the Investigational New Drug (IND) application for HLX3901…has been approved by the National Medical Products Administration (NMPA), for the treatment of advanced and metastatic solid tumors. (Henlius Press Release) - "It is expected to offer a breakthrough immunotherapy option for patients with neuroendocrine carcinoma(NEC)such as small cell lung cancer (SCLC)."

New trial • Neuroendocrine Carcinoma • Small Cell Lung Cancer

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC (clinicaltrials.gov) - P1 | N=138 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

First-in-human • New P1 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3