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

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.

NCT Number	NCT07541534
Lead Sponsor	Shanghai Henlius Biotech
Conditions	Advanced/Metastatic Solid Tumors
Enrollment	41 participants
Start Date	2026-05-22
Primary Completion	2027-12-01 (estimated)
Study Completion	2029-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-28