Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Sol… (NCT07021066) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
United States160 participantsStarted 2025-07-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed the informed consent form voluntarily and agreed to follow the program requirements.
. Age ≥18 years.
. Life expectancy of ≥3 months.
. Dose Escalation and Dose Finding (Parts 1 and 2): Documented locally advanced or metastatic solid tumor(s) 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 (refer to Section 6.3.1), have no other standard of care options, and have no available curative options, including the following:
. Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AC): Participants with CLDN18.2, HER2, PD-L1, and/or microsatellite instability high (MSI-H)/mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy.
. Pancreatic ductal AC (PDAC): Participants who have received at least 1 line of standard therapy.
. Esophageal AC (EAC): Participants with HER2, PD-L1, and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy.
. Biliary tract cancers (BTCs): Participants with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations, and/or MSI-H/ dMMR positive tumors must have received targeted treatment in their prior lines of therapy.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since BL-M05D1 is in Phase 1 and the trial is mainly focused on finding a safe dose and understanding side effects, what does that mean for me in terms of how much is known about whether it actually works against my specific cancer type?
2This trial is no longer actively recruiting — does that affect any possibility of me joining, or is there a related or follow-on study I should know about?
3The trial is tracking serious side effects, heart function through ECG and ECHO tests, and lab results very closely — what kind of monitoring schedule would that mean for me in terms of visits, tests, and time commitment?
4My cancer type is one of several being studied here, including gastric, pancreatic, esophageal, biliary tract, and other solid tumors — would my specific diagnosis be a good or poor fit for what the researchers are trying to learn, and does that affect what I might get out of participating?
5Before considering a Phase 1 trial like this one, are there standard treatments or approved therapies I should try first, and how would joining this study affect my ability to access those options later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants with Dose-limiting toxicities
Timeframe: 1 year
2
Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)
Timeframe: 1 year
3
Participants with abnormal physical examination findings
Timeframe: 1 year
4
Participants with ability to care for themselves, daily activity, and physical activity
Timeframe: 1 year
5
Participants with abnormal ECG and ECHO/MUGA reading
Timeframe: 1 year
6
Participants with abnormal lab results
Timeframe: 1 year
7
To determine the maximum tolerated dose (MTD) if reached or minimum safe and pharmacologically effective dose (MSED).
. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small-molecule inhibitor of tyrosine kinase), or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration of study drug; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration.
. Participants with history of severe heart disease such as symptomatic congestive heart failure (CHF) Grade ≥2 (CTCAE v5.0), New York Heart Association (NYHA) Grade ≥2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment.
. Participants with prolonged QT interval corrected (QTcF) \>470 msec, complete left bundle branch block, Grade 3 atrioventricular block.
. Active autoimmune diseases and inflammatory diseases such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, or Hashimoto's thyroiditis..
. Participants with other prior malignancies.
. Participants with advanced or clinically significant lung diseases such as poorly controlled chronic obstructive pulmonary disease (COPD) or asthma, restrictive lung disease, or pulmonary hypertension.
. Participants who have a history of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids or have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
. Participants with stroke or transient ischemic attack (TIA) within 6 months before enrollment.