Actively Recruiting
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
Led by SystImmune Inc. · Updated on 2026-03-23
280
Participants Needed
17
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
CONDITIONS
Official Title
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Life expectancy of at least 3 months
- Documented locally advanced or metastatic HER2 expressing solid tumor not suitable for curative surgery or radiation
- Have received at least two lines of standard therapy or have cancer refractory to standard treatment or no available standard treatment
- Tumor types include endometrial, cervical, ovarian, urothelial, biliary tract, breast, lung, gastric, gastroesophageal junction, or esophageal cancers
- Agree to provide most recent tumor samples for HER2 expression testing
- At least one measurable lesion per RECIST V1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Previous antitumor therapy toxicity returned to Grade 1 or less
- No serious cardiac dysfunction; left ventricular ejection fraction 50% or higher
- Adequate organ function including coagulation and urinary protein levels
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days prior to treatment
- Agree to use adequate contraception during treatment and for 6 months after treatment
You will not qualify if you...
- Antitumor therapy within 4 weeks or 5 half-lives prior to first administration; major surgery within 4 weeks; mitomycin and nitrosoureas treatment within 6 weeks prior to first administration
- History of severe heart disease
- Prolonged QT interval, complete left bundle branch block, or Grade 3 atrioventricular block
- Active autoimmune or inflammatory diseases
- Other malignant tumors diagnosed within 3 years prior to first administration considered in remission
- Poorly controlled hypertension despite two antihypertensive drugs
- Advanced or significant lung diseases like COPD, asthma, restrictive lung disease, pulmonary hypertension
- Stroke or transient ischemic attack within 6 months before enrollment
- Recent thromboembolic events within 6 months unless stable and adequately treated
- Primary central nervous system tumors or active/untreated brain metastases; stable treated brain metastases allowed under conditions
- Pre-existing Grade 2 or higher peripheral neuropathy
- Allergies to recombinant humanized or human-mouse chimeric antibodies or components of BL-M07D1
- Use of systemic glucocorticoids >10 mg/day prednisone equivalent except for specified conditions
- Prior anthracycline treatment exceeding 360 mg/m2 cumulative dose
- Known HIV infection unless undetectable viral load and stable therapy criteria met
- Active hepatitis C virus infection unless RNA negative
- Active tuberculosis
- Active infections requiring intravenous antimicrobial treatment within 1 week prior to first dose
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Any other condition deemed unsuitable by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
Cedars Sinai
Los Angeles, California, United States, 90211
Actively Recruiting
4
Scripps Health
San Diego, California, United States, 92121
Not Yet Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Sarah Cannon Research institute - Lake Nona Florida
Orlando, Florida, United States, 32827
Actively Recruiting
7
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
8
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
9
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
10
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
Karmanos Cancer Institiute
Detroit, Michigan, United States, 48201
Actively Recruiting
12
NYU Langone Hospital - Long Island Investigational Pharmacy
Mineola, New York, United States, 11501
Actively Recruiting
13
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
14
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
15
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
17
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Christine LaRock
CONTACT
W
Whitney Eakins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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