Actively Recruiting
Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
26
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
S
SystImmune Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluation of BL-M07D1 for injection in Phase I clinical study of safety, tolerability, pharmacokinetic Characteristics, and initial efficacy in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.
CONDITIONS
Official Title
Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow study procedures
- Age 18 to 75 years (Phase Ia) or 18 years and older (Phase Ib)
- Locally advanced or metastatic HER2-positive or low-expression digestive tract tumors or other solid tumors confirmed by pathology
- Tumors not operable and failed or not suitable for standard therapy
- At least one measurable lesion per RECIST v1.1
- ECOG performance status 0 or 1
- Recovery from previous antitumor therapy toxicities to grade 1 or better (except certain lab abnormalities)
- No serious cardiac abnormalities; left ventricular ejection fraction at least 50%
- Adequate bone marrow, liver, kidney, and coagulation function as specified
- Urine protein level less than or equal to 2+ or 1000 mg/24h
- Albumin level at least 30 g/L
- Negative pregnancy test within 7 days before treatment for premenopausal women; use of effective contraception during and 6 months after treatment
You will not qualify if you...
- Received chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery, or targeted therapy within 4 weeks prior to first dose (with some exceptions)
- Prior antibody-drug conjugate therapy using camptothecin derivatives (Phase Ib only)
- History of severe heart disease, such as symptomatic congestive heart failure (grade 2 or higher), unstable angina, or recent heart attack
- Prolonged QT interval or serious heart conduction abnormalities
- Active autoimmune or inflammatory diseases requiring systemic treatment
- Other cancers diagnosed within 3 years except certain cured cancers
- Unstable blood clots requiring treatment within 6 months
- Poorly controlled fluid buildup like pericardial, pleural, or abdominal effusions
- Poorly controlled high blood pressure
- Significant lung disease or recent lung radiation therapy
- Active brain metastases (stable brain metastases may be allowed)
- Allergy to humanized or chimeric antibodies or components of BL-M07D1
- Previous organ or stem cell transplantation
- High cumulative dose of anthracyclines
- Positive for HIV or active hepatitis B or C infection
- Active infections requiring systemic treatment
- Participation in another clinical trial within 4 weeks prior to first dose
- Pregnant or nursing women
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, China, 200100
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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