Macquarie

Researchers are evaluating ALK201, an investigational drug, in adults with advanced solid tumors to assess its safety, tolerability, how the body processes it, and its potential antitumor effects. This first-in-human, open-label study aims to find the best dose for future research. The study is sponsored by Shanghai Allink Biotherapeutics Co., Ltd. and includes adults aged between 18 and 75 years with measurable tumors and good overall health status. The study has two parts Part A is a dose-escalation phase to determine the maximum tolerated dose and the doses for further study, while Part B is a dose-expansion phase enrolling selected patient groups. ALK201 is given intravenously once every three weeks. The study will monitor participants closely during and after treatment to understand the drugs effects and safety profile. Participants will undergo various evaluations including tumor measurements, laboratory tests, and assessments of organ function and immune response over approximately 36 months. Researchers will also track pharmacokinetics and biomarkers to evaluate treatment impact. Safety and tolerability will be assessed continuously, and participants will be followed to observe preliminary antitumor activity and immunogenicity.

Researchers are conducting a first-in-human, open-label, multicenter Phase IaIb study to evaluate AMT-676, an antibody-drug conjugate targeting CDH17, in patients with advanced solid tumors. This early-phase trial aims to determine the recommended dose for further studies and assess safety, tolerability, and preliminary efficacy in patients whose cancers have progressed after standard treatments. The study is sponsored by Multitude Therapeutics Inc. Participants will receive AMT-676 through intravenous infusion. The study includes dose escalation to identify the maximum tolerated dose and recommended Phase 2 dose. During treatment, patients will be monitored for dose-limiting toxicities and adverse events. The study period involves treatment administration and follow-up lasting at least 30 days after the last dose to assess safety and drug behavior. Throughout the trial, participants will undergo regular assessments including tumor measurements based on RECIST criteria, laboratory tests for organ function, and monitoring for adverse effects. Researchers will measure key outcomes such as dose recommendations, safety profiles, drug concentration in blood, immune response against the drug, and clinical response of tumors. The study requires patients to have measurable disease and adequate health status to participate, with ongoing evaluation during and after treatment to ensure safety and collect comprehensive data.