Actively Recruiting
A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-06-15
30
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary informed consent and follow the study protocol
- Any gender can participate
- Age between 18 and 75 years old
- Expected survival of at least 3 months
- Confirmed locally advanced or metastatic solid tumors with failure or intolerance to standard treatment or no current standard treatment
- Willing to provide archival or fresh tumor tissue samples within the past 3 years
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Toxicity from previous anti-cancer therapy has resolved to grade 1 or less per NCI-CTCAE v5.0
- No severe heart dysfunction; left ventricular ejection fraction at least 50%
- No blood transfusions or use of growth factor drugs within 14 days before screening; adequate organ function
- Coagulation tests within normal limits: INR ≤1.5 and APTT ≤1.5 times upper limit of normal
- Urinary protein less than or equal to 2+ or less than or equal to 1000 mg/24h
- Premenopausal women with childbearing potential must have negative pregnancy test within 7 days before treatment start and not be breastfeeding
- All patients advised to use effective contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Anti-tumor therapies (chemotherapy, biological therapy, immunotherapy) within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral fluorouracil or palliative radiotherapy within 2 weeks; Chinese patent medicine within 2 weeks before treatment
- History of severe cardiovascular or cerebrovascular diseases
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmias
- Active autoimmune or inflammatory diseases
- Other malignancies diagnosed within 5 years before treatment
- Poorly controlled hypertension despite two antihypertensive drugs
- History or suspicion of interstitial lung disease or radiation pneumonitis grade 1 or higher
- Pulmonary disease grade 2 or higher causing severe respiratory impairment
- Poor blood sugar control
- Active central nervous system metastases
- Massive, symptomatic, or poorly controlled effusions
- Tumor invasion or encasement of major blood vessels in chest, neck, or pharynx
- History of pulmonary embolism or thrombotic events needing treatment within 6 months
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any BL-M05D1 ingredients
- Prior organ or stem cell transplantation
- Cumulative anthracycline dose greater than 360 mg/m2 in previous therapy
- Positive for HIV antibody, active tuberculosis, or active hepatitis B or C infections
- Active infections needing systemic treatment
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or breastfeeding women
- Investigator deems participation inappropriate for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
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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