Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

BL-M05D1-ST-101: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.


Why this Research Matters

This is a multicenter Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M05D1 in subjects with unresectable locally advanced or metastatic solid tumors that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant/neoadjuvant), have no other standard of care options, and have no available curative options. This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Subjects will be dosed on Day 1 on a continuous 21-day treatment cycle.


Who can Participate

Adult

Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study. https://clinicaltrials.gov/study/NCT07021066?term=NCT07021066&rank=1


Study ID

Protocol Number: 25-1878

More information available at ClinicalTrials.gov: NCT07021066


Meet the Team

Image of Principal Investigator

Sunnie Kim, MD

Principal Investigator