BL-M07D1 for HER2 Expressing Solid Tumors
This study is testing a drug called BL-M07D1 for people with advanced solid tumors that have a specific marker called HER2. The tumors being studied include endometrial, cervical, ovarian, urothelial (bladder), and biliary tract cancers. Researchers want to see how safe BL-M07D1 is, how well your body handles it, and if it helps treat these cancers. The study is open to adults aged 18 and older who have a life expectancy of at least 3 months. The study is currently unclear on its recruitment status and plans to enroll about 280 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know you are receiving BL-M07D1. It has three parts: dose escalation, dose finding, and dose expansion, with some parts being randomized. The study aims to enroll about 280 participants.
- What's involved
- You would receive BL-M07D1 as an intravenous infusion (through a vein) every 3 weeks on Day 1 of each cycle. The study will measure safety throughout the study, which is expected to last an average of 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure safety throughout the study, which is expected to last an average of 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
At a glance
Conditions
Where it's being run
17 sites across 12 statesStudy leadership
- Clinical Leader · 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
- Summary of safetyThough study completion, an average of 24 months
The number of patients with dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam findings, vital signs, laboratory tests, ECG parameters and echocardiograph
- To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D121 Days
Determine the highest BL-M07D1 dose level at which subjects do not experience a DLT during the DLT evaluation period and highest BL-M07D1 dose administered in the event and MTD cannot be defined.