Phase 1 Study of BL-B01D1 Treatment for Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of BL-B01D1 in adults with metastatic or unresectable non-small cell lung cancer NSCLC and other solid tumors. This global, multi-center Phase 1 study focuses on patients with cancers that cannot be surgically removed or have spread, including several specific tumor types such as breast, esophageal, and prostate cancer. The trial aims to determine the best doses and schedules for BL-B01D1 treatment while monitoring potential side effects and drug behavior in the body. BL-B01D1 is given intravenously in two dosing schedules Cohort A receives the drug on Day 1 and Day 8 of a 21-day cycle, while Cohort B receives it only on Day 1 of each cycle. The study consists of three parts dose escalation, dose finding, and dose expansion. Each cohort includes different dose groups to identify the maximum tolerated dose and the recommended doses for further study. Participants receive treatment every three weeks according to their assigned group. During the study, participants will have regular assessments including physical exams, lab tests, ECGs, and evaluations of their daily activity and ability to care for themselves. Researchers will observe adverse events and measure drug levels in the blood to understand its effects. The main outcomes include safety measures, dose tolerance, and tumor response. The trial will follow participants for up to one year to monitor treatment impact and overall survival.

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors