Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
{ "Study of BL-M05D1 for Advanced Solid Tumors", "This study is testing a new drug called BL-M05D1 for people with advanced solid tumors, including stomach (gastric), pancreatic, esophageal, and biliary tract cancers. The main goals are to see if BL-M05D1 is safe, how well your body handles it, and if it helps treat the cancer. You might be able to join if you have a solid tumor that has grown or come back after other treatments and potentially expresses CLDN18.2 (a protein on cancer cells). Researchers will be looking for side effects and how your body processes the drug. The study plans to include about 160 participants.", "design": "This is an open-label study, meaning you and your doctors will know you are receiving BL-M05D1. It is a Phase 1 study, which typically focuses on safety and dosage, and will include about 160 participants.", "commitments": "You would receive BL-M05D1 as an infusion on Day 1 of a continuous 21-day treatment cycle. The study will monitor for side effects, serious adverse events, and changes in your physical exam for up to one year.", "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 up to one year.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
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 the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
At a glance
Conditions
NCT07021066
Where you'd take part
This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hackensack University Medical Center
Hackensack, New Jerseyno site contact published
HonorHealth
Scottsdale, Arizonano site contact published
NEXT Oncology San Antonio
San Antonio, Texasno site contact published
NEXT Oncology- Austin
Austin, Texasno site contact published
NEXT Oncology- Dallas
Dallas, Texasno site contact published
Ochsner Medical Center
New Orleans, Louisianano site contact published
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennesseeno site contact published
University of Colorado Health
Aurora, Coloradono site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sarah Tannenbaum · STUDY_DIRECTOR · SystImmune Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Participants with Dose-limiting toxicities1 year
A DLT is defined as the following: Toxicity that results in a \>14-day delay in treatment \- Hematologic toxicities Grade 4 neutrophil count decreased lasting \>7 days Grade ≥3 febrile neutropenia of any duration Grade ≥3 platelet count decreased with clinically significant hemorrhage Grade 4 thrombocytopenia lasting \>72 hours \- Nonhematologic toxicities Death not clearly related to disease progression or extraneous cause Hy's law cases Grade ≥3 nonhematologic toxicities, except for: Grade 3 nausea/vomiting or diarrhea for less than 72 hours with adequate antiemetic and other supportive care Grade 3 fatigue for less than 1 week Grade ≥3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical interventions Grade ≥3 amylase or lipase that is not associated with symptoms or clinical manifestations of pancreatitis
- Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)1 year
Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
- Participants with abnormal physical examination findings1 year
Measure the number of participants with abnormal physical examination findings.
- Participants with ability to care for themselves, daily activity, and physical activity1 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 and ECHO/MUGA reading1 year
Patients with abnormal ECG parameters (including the change from-baseline ECG parameters: heart rate \[HR\]; PR; QTcF; and QRS intervals \[∆HR, ∆PR, ∆QTcF, and ∆QRS\]), and ECHO/MUGA findings
- Participants with abnormal lab results1 year
Measure the number of participants with abnormal clinical laboratory values
- To determine the maximum tolerated dose (MTD) if reached or minimum safe and pharmacologically effective dose (MSED).1 year
The actual number of subjects enrolled and dose levels to be explored in this study will depend on the MTD and/or MSED based on DLTs reported during the DLT observation period.