Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the first subject dosed in a Phase I clinical trial in Australia for its independently developed HLX60 (recombinant anti-GARP humanized monoclonal antibody injection) in combination with Henlius’s innovative in-house anti-PD-1 mAb serplulimab. The trial is assessing the combination in treating general advanced or metastatic solid tumors.
Study Design and Objectives
This Phase 1 study is designed to assess the safety, tolerability, and preliminary efficacy of HLX60 plus serplulimab, and will follow an accelerated titration design (ATD) in combination with a “3+3” design. Eligible subjects will be given different doses of HLX60 as monotherapy (Q3W: 0.5, 2, 5, 15, and 25 mg/kg) intravenously in cycle 1, and then combined with serplulimab (Q3W: 300 mg) starting from cycle 2. The primary endpoints are dose-limiting toxicities (DLT) assessed within three weeks after the first dose of HLX60, as well as the maximum tolerated dose (MTD) of HLX60 and recommended phase 2 dose (RP2D) of HLX60 plus serplulimab. Secondary endpoints include safety, pharmacokinetic parameters, pharmacodynamic characteristics, immunogenicity, and efficacy.
Serplulimab: Approved and Under Review in China
Serplulimab has been approved in China to treat unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy, and combined with chemotherapy in first-line squamous non-small cell lung cancer (sqNSCLC). Supplementary New Drug Applications (sNDAs) for the drug combined with chemotherapy in first-line ES-SCLC and first-line esophageal squamous cell carcinoma (ESCC) were accepted for review in China in April and August of 2022, respectively. Multiple clinical studies for the drug are well underway around the globe.
HLX60: Targeting GARP for Solid Tumors and Lymphomas
HLX60 is an in-house developed glycoprotein A repetitions predominant (GARP)-targeted monoclonal antibody (mAb) being developed to treat solid tumors and lymphomas. GARP is highly expressed on the surface of activated regulatory T cells (Treg), platelets, and some tumor cells. HLX60 can bind to GARP and specifically block the release of TGF-β1 mediated by GARP, thereby releasing the immunosuppression formed by TGF-β1 and improving the anti-tumor immune response.-Fineline Info & Tech
