Piqueras

Researchers are evaluating the safety, tolerability, and initial effectiveness of a drug called BL-B01D1 in people with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors. This global, multi-center Phase 1 study includes various types of cancers such as breast, esophageal, small cell lung, nasopharyngeal, head and neck, prostate, ovarian, endometrial, cervical, and triple-negative breast cancer. The study aims to determine the maximum tolerated dose or maximum administered dose and identify recommended doses and schedules for further study. The study is organized into three parts: dose escalation, dose finding, and dose expansion. Participants will be divided into two groups, Cohort A and Cohort B, based on dosing schedules. Cohort A receives BL-B01D1 on Day 1 and Day 8 of a continuous 21-day cycle, while Cohort B receives BL-B01D1 only on Day 1 of the cycle. Different dose groups exist within each cohort to assess safety and dosing. The study drug BL-B01D1 is administered as an intravenous drug during these cycles. Participants will be involved for up to one year, during which researchers will monitor dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam changes, ability to care for themselves and perform daily and physical activities, ECG readings, and lab test results. The study also tracks pharmacokinetics and initial drug efficacy. Safety and tolerability will be carefully assessed throughout the study, with regular evaluations to understand the best dose and schedule for future research.