Phase I Trial Evaluating Safety and Dosage of HLX48 in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating HLX48, an EGFRc-MET bispecific antibody-drug conjugate, in patients with advanced or metastatic solid tumors. This open-label phase I clinical trial aims to assess the safety, tolerability, and pharmacokinetic profile of HLX48 given at increasing doses. The trial uses a 33 dose escalation design to carefully study the effects and side effects of HLX48 in this patient population. Participants will receive HLX48 via intravenous infusion at one of six preset dose levels. The dose-limiting toxicity DLT observation period lasts for 3 weeks after the first dose, during which the Safety Review Committee reviews safety data to decide on dose escalation or cohort expansion. New dose groups may be added based on safety, tolerability, pharmacokinetics, immunogenicity, and efficacy data. Those who withdraw early for reasons unrelated to toxicity may be replaced. Throughout the study, participants will undergo evaluations including tumor measurements by RECIST v1.1, ECOG performance status assessments, and laboratory tests to confirm organ function. Safety monitoring includes dose-limiting toxicity and maximum tolerated dose assessments within the first cycle of treatment. Secondary outcomes such as response rates, survival, and antibody development will be tracked for up to 24 months. Participants are followed closely during and after treatment to collect comprehensive data on HLX48s effects.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors