Phase I Study of HLX42 to Assess Safety and Tolerability in Adults with Advanced or Metastatic Solid Tumors including NSCLC

What this Trial Is About

Researchers are evaluating HLX42, an investigational anti-EGFR antibody drug conjugate, in patients with advanced or metastatic solid tumors including non-small cell lung cancer NSCLC. This open-label, first-in-human phase I study aims to assess the safety and tolerability of HLX42, focusing on dose-limiting toxicities and maximum tolerated dose. The study includes patients whose tumors are resistant or intolerant to standard treatments or for whom no standard therapy exists. The trial has two stages initially, a dose escalation phase using a 33 design where patients receive escalating doses of HLX42 via intravenous infusion and are monitored for toxicities during the first 3 weeks. In the second stage, about 60 patients are randomized into two groups receiving fixed doses of HLX42 at 2.5 mgkg or 2.0 mgkg every three weeks. Treatment continues until disease progression, intolerable side effects, or patient withdrawal. Participants will undergo regular assessments including tumor measurements by RECIST 1.1 criteria, laboratory tests, and evaluations of organ function. Safety is closely monitored through adverse event recording up to 90 days after the last dose. The study will also evaluate pharmacokinetic characteristics and anti-drug antibodies over approximately 24 months, with survival outcomes tracked during this period. Treatment tolerability and clinical benefit guide ongoing therapy decisions throughout the trial.

A Study of HLX42 in Advanced/Metastatic Solid Tumors