KEY TAKEAWAYS
- The phase I trial aimed to evaluate the safety, tolerability, and pharmacokinetics of HLX26 in patients with advanced solid tumors or lymphomas.
- The primary endpoints were to determine MTD and DLTs that occur within 3 weeks of the first dose. The secondary endpoints were to assess the safety, pharmacokinetics, pharmacodynamics, preliminary efficacy, immunogenicity, and potential biomarkers of HLX26.
- The study found that HLX26 was safe and well tolerated in patients with advanced or metastatic solid tumors.
HLX26 is a novel monoclonal antibody targeting LAG3 that has been humanized. Researchers aimed to evaluate the safety, tolerability, and pharmacokinetics of HLX26 in patients with advanced solid tumors or lymphomas.
The study enrolled advanced solid tumors or lymphoma patients not responding to standard therapies. They received HLX26 at different dose levels intravenously until disease progression, 2 years of treatment, intolerable toxicity, withdrawal of consent, or death. The primary endpoints were dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) within 3 weeks after the first dose. Secondary endpoints included safety, pharmacokinetics, efficacy, immunogenicity, and biomarker explorations of HLX26.
About 12 patients with stage IV breast (n = 10) or rectum (n = 2) tumors received HLX26 at varying doses (60 mg, 150 mg, 300 mg, 500 mg, or 800 mg). The mean age was 57.5 years (range: 31–73). No DLTs were reported, and MTD was not determined yet. Around 11 (91.7%) patients experienced treatment-emergent adverse events (TEAEs), with the most common being hypercholesterolemia (41.7%), hypertriglyceridemia (25.0%), and hyperuricemia (25.0%). Most TEAEs were grade 1 (n = 8, 66.7%) and grade 2 (n = 2, 16.7%).
The study found that HLX26 demonstrated a favorable safety profile with no new safety signals observed across the dose range (60 mg to 800 mg) and was well tolerated in patients with advanced or metastatic solid tumors.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e14671?af=R
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05078593
Rujiao Liu, Jian Zhang, Yang Chen, Shuiping Gao, Chen Hu, Liang Zhou, Hua Li, Wenying Kang, and Jun Zhu. Journal of Clinical Oncology 2023 41:16_suppl, e14671-e14671.
