BL-B01D1 for Metastatic or Unresectable Cancers
This study is testing a drug called BL-B01D1 in people with metastatic (spread to other parts of the body) or unresectable (cannot be removed by surgery) non-small cell lung cancer (NSCLC) and other solid tumors, including breast cancer and esophageal cancer. The main goals are to see how safe BL-B01D1 is, how well people tolerate it, and if it shows any early signs of working. You might be able to join if you are at least 18 years old, have a life expectancy of at least 3 months, and have one of the specified cancer types. The study will look at side effects like dose-limiting toxicities and serious adverse events over one year.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 470 participants and will explore two different dosing schedules for BL-B01D1.
- What's involved
- BL-B01D1 will be given either once every 21 days or on Day 1 and Day 8 of a 21-day cycle. The study will involve physical examinations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for dose-limiting toxicities, serious adverse events, and abnormal physical examination findings for one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
At a glance
Conditions
Where it's being run
39 sites across 19 statesStudy leadership
- Jimmy Zhao, MD, PhD · STUDY_DIRECTOR · SystImmune Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Participants with Dose-limiting toxicitiesOne year
Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematological toxicities: * Grade 4 neutrophil count decreased lasting \>7 days * Grade ≥3 febrile neutropenia * Grade ≥3 platelet count decreased with clinically significant hemorrhage. Non-Hematological toxicities: * Death * Hy's law cases * Grade ≥3 non-hematological toxicities,
- Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs),One year
Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
- Participants with abnormal physical examination findingsOne year
Measure the number of participants with abnormal physical examination findings.
- Participants with ability to care for themselves, daily activity, and physical activityOne year
Measure the change in participants with Eastern Clinical Oncology Group (ECOG) Scale of Performance Status. The scale is 0-4 with 0 being the fully active (best outcome) and 4 being completely disabled (worst outcome)
- Participants with abnormal ECG readingOne year
Measure the number of participants with abnormal ECG parameters
- Participants with abnormal lab resultsOne year
Measure the number of participants with abnormal clinical laboratory values
- To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and two or more recommended doses and schedules for recommended dose expansion (RDEs) of BL-B01D1 in metastatic NSCLCOne year
Determine the highest BL-B01D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-B01D1 dose administered in the event and MTD cannot be defined.