Actively Recruiting
A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-08
42
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors.
CONDITIONS
Official Title
A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with the protocol requirements
- No gender restrictions
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors
- Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years
- Must have at least one measurable lesion as defined by RECIST v1.1
- ECOG performance status score of 0 or 1
- Toxicity from prior anti-tumor therapy has recovered to Grade 1 or less as defined by NCI-CTCAE v5.0
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) of 50% or higher
- Organ function levels must meet the requirements
- Coagulation function: International Normalized Ratio (INR) of 1.5 or less, and activated partial thromboplastin time (APTT) of 1.5 times upper limit of normal (ULN) or less
- Urine protein of 2+ or less, or 1000 mg/24h or less
- Albumin level of 30 g/L or higher
- Premenopausal women with childbearing potential must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding
- All enrolled patients must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends
You will not qualify if you...
- Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose
- Previously treated with ADC drugs containing camptothecin derivatives as payloads
- History of severe cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases
- History of other malignancies within 5 years prior to the first dose
- Thrombotic events requiring therapeutic intervention within 6 months before screening
- Significant pleural, peritoneal, pelvic, or pericardial effusion, symptomatic or poorly controlled
- Poorly controlled hypertension despite medication
- Current or history of interstitial lung disease, drug-induced pneumonitis, or radiation pneumonitis requiring steroid treatment
- Primary central nervous system tumors or CNS metastases that failed local treatment
- History of hypersensitivity to recombinant humanized antibodies, human-mouse chimeric antibodies, or any excipients of BL-M07D1
- Previous organ or allogeneic hematopoietic stem cell transplantation
- Positive for HIV antibodies, active tuberculosis, or active hepatitis C infection
- Active hepatitis B infection
- Severe infection requiring systemic treatment within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or lactating women
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
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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