Phase I Study to Evaluate Safety and Anti-Tumor Effects of ALPS12 in Adults with Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating ALPS12 in patients with extensive-stage small cell lung cancer in this phase I, open-label, multicenter trial. The study aims to assess the safety, tolerability, how the drug moves through the body, immune response, and early signs of tumor control. The trial includes two parts a dose-escalation phase to find the best dose and an expansion phase to further study the drugs effects. Participants will receive ALPS12 as an intravenous infusion after pretreatment with obinutuzumab, another IV drug. The dose-escalation part focuses on identifying the maximum tolerated dose by monitoring dose-limiting toxicities, while the expansion part evaluates the antitumor activity of ALPS12 at selected doses. Both parts involve careful administration and observation of the drugs. During the study, participants will be monitored closely with safety checks, blood tests, tumor assessments, and immune response measurements. Researchers will track adverse events, drug levels in the body, and tumor response using recognized criteria. The study lasts approximately 42 months from screening to completion or treatment discontinuation, ensuring thorough follow-up and evaluation throughout.

A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER