Phase I Study to Evaluate Safety, Dosage, and Early Effects of HLX316 in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating HLX316, a B7-H3 targeting sialidase Fc fusion protein, in people with advanced or metastatic solid tumors, including platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This early Phase I trial aims to assess the safety, tolerability, how the body processes the drug, and its preliminary ability to affect tumors. The study includes two parts a dose-escalation phase and a dose-expansion phase focusing on determining effective dose levels and early treatment effects. Participants will receive HLX316 through intravenous infusion once weekly at varying dose levels 1, 3, 10, 20, or 30 mgkg. The initial dose-escalation phase will assign participants to different dose groups to evaluate safety and pharmacokinetics. Based on these results, the second phase will expand dosing at selected levels, tentatively 10 mgkg and 20 mgkg, to further explore treatment effects. Treatment cycles repeat every week as part of this process. Throughout the study, participants will undergo regular safety assessments to monitor side effects and dose-limiting toxicities during a 21-day evaluation period. Effectiveness will be measured by tumor response rates over six months, with ongoing monitoring of duration of response, progression-free survival, and overall survival up to 24 months. Laboratory tests, imaging, and tumor tissue analysis will help researchers understand the drugs effects and participant health. The trial may last up to several years with continuous safety and efficacy evaluations.

A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors