Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
Led by SystImmune Inc. · Updated on 2026-04-30
160
Participants Needed
17
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreed to follow study requirements
- Age 18 years or older
- Life expectancy of at least 3 months
- Documented locally advanced or metastatic solid tumor potentially expressing CLDN18.2 that has recurred or progressed after at least one prior systemic therapy with no other standard or curative options
- For specific tumor types, prior targeted treatments must have been received if applicable
- Agree to provide recent tumor tissue samples or fresh biopsy for CLDN18.2 evaluation
- At least one measurable lesion based on RECIST v1.1
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
- Toxicities from previous therapies have resolved to Grade 1 or lower (except certain controlled conditions up to Grade 2)
- No serious cardiac dysfunction with left ventricular ejection fraction of 50% or higher
- Adequate marrow, liver, and kidney function as defined by specified laboratory values
- Coagulation parameters within specified limits unless on anticoagulation therapy
- Urine protein less than or equal to 2+ or 1000 mg/24 hours
- Agree to use highly effective contraception during and after the study if sexually active and fertile
- Women of childbearing potential must have a negative pregnancy test and be nonlactating
You will not qualify if you...
- Recent chemotherapy, biological therapy, immunotherapy, radiotherapy, targeted therapy, or major surgery within specified timeframes before study start
- History of severe heart disease including congestive heart failure Grade 2 or higher, recent myocardial infarction, or unstable angina
- Prolonged QT interval, complete left bundle branch block, or high-grade atrioventricular block
- Active autoimmune or inflammatory diseases requiring systemic treatment, except well-controlled conditions
- Prior malignancies except certain skin cancers or those treated with curative intent and disease-free for at least 3 years
- Poorly controlled hypertension
- Significant lung diseases or history of interstitial lung disease/pneumonitis requiring steroid treatment
- Recent stroke or transient ischemic attack
- Recent thromboembolic events unless stable on anticoagulants
- Active or untreated central nervous system tumors or metastases
- Pre-existing Grade 2 or higher peripheral neuropathy
- History of anaphylaxis or severe hypersensitivity to similar antibodies or study drug components
- Use of systemic glucocorticoids above specified dose except for defined exceptions
- Prior anthracycline treatment exceeding specified cumulative dose
- Known HIV infection unless stable on treatment with undetectable viral load
- Active hepatitis B or C infections unless meeting stability criteria
- Active tuberculosis or infections requiring intravenous antimicrobial therapy
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Mayo Clinic Cancer Center- Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
HonorHealth
Scottsdale, Arizona, United States, 85266
Actively Recruiting
3
University of Colorado Health
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
10
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
12
NEXT Oncology- Austin
Austin, Texas, United States, 78758
Actively Recruiting
13
NEXT Oncology- Dallas
Dallas, Texas, United States, 75039
Actively Recruiting
14
MD Anderson
Houston, Texas, United States, 77030
Not Yet Recruiting
15
NEXT Oncology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
16
START Center for Care Center- San Antonio
San Antonio, Texas, United States, 78229
Not Yet Recruiting
17
Baylor Scott and White Medical Center- Temple Clinic
Temple, Texas, United States, 76504
Actively Recruiting
Research Team
S
Stephanie Yee
CONTACT
W
Whitney Eakins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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