A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX316 (B7-H3 Targeting Sialidase Fc Fusion Protein) in Participants With Advanced/Metastatic Solid Tumors
Shanghai Henlius Biotech
41 participants
May 22, 2026
INTERVENTIONAL
Conditions
Summary
This study is an open-label, first-in-human Phase I clinical study to evaluate the safety, tolerability, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors. The study will consist of 2 parts: a Phase Ia dose-escalation part and a Phase Ib dose-expansion part. Phase Ia and Phase Ib will focus on exploring the preliminary antitumor activity of HLX316 in participants with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will receive HLX316 administered by intravenous infusion on D 1 of each cycle, with a cycle length of 1 week.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07541534