Phase I Study of BL-M14D1 for Treating Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors, and Other Solid Tumors

What this Trial Is About

Researchers are evaluating BL-M14D1 in people with locally advanced or metastatic small cell lung cancer, neuroendocrine tumors, and other solid tumors that cannot be cured or lack standard treatment options. This open, multicenter, phase I clinical study aims to assess the safety, tolerability, how the drug moves through the body pharmacokinetics, and early signs of effectiveness of BL-M14D1 in these patients. Participants receive BL-M14D1 through an intravenous infusion over a 3-week cycle. Those who show clinical benefit may continue treatment for additional cycles until disease progression, unacceptable side effects, or other reasons require stopping. The study includes dose escalation and expansion stages to determine appropriate dosing and safety. During the study, participants will be monitored for side effects, blood levels of the drug, immune reactions, and tumor response using clinical and imaging assessments. Researchers will measure outcomes such as dose-limiting toxicity, maximum tolerated dose, objective response rate, disease control rate, and duration of response. Follow-up and safety evaluations may continue for up to 24 months from the first dose.

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors