Actively Recruiting
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy 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
N/A
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
Researchers are evaluating BL-M05D1 in patients with locally advanced or metastatic solid tumors in a phase I, open-label, multicenter study. This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of BL-M05D1 in individuals who have not responded to or cannot use standard treatments. Participation includes adults aged 18 to 75 years with measurable tumors and an expected survival of at least three months. Participants receive BL-M05D1 through intravenous infusion for an initial 3-week treatment cycle. Those who show clinical benefit may continue treatment in additional cycles. Treatment will stop if the disease progresses, intolerable side effects appear, or for other reasons. The study includes dose escalation to find the maximum tolerated dose and recommended dose for further trials. During the study, participants will undergo assessments for dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose up to about 24 months. Researchers will monitor adverse events, drug concentration levels, and immune responses, along with tumor response and disease control rates. Safety, tolerability, and pharmacokinetic data will be collected regularly to evaluate the treatment effects and patient health over time.
CONDITIONS
Brief 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...
- Signed informed consent and willingness to follow protocol requirements
- Any gender
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Locally advanced or metastatic solid tumors confirmed by histopathology or cytology with failure or intolerance to standard treatment or no current standard treatment
- Consent to provide archival or fresh tumor tissue samples within 3 years
- At least one measurable lesion by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovery from toxicity of previous antineoplastic therapy to grade 1 or less (NCI-CTCAE v5.0)
- No severe cardiac dysfunction with left ventricular ejection fraction of 50% or greater
- No blood transfusion or use of growth factors within 14 days prior to screening; organ function meets requirements
- Coagulation function with INR of 1.5 or less and APTT of 1.5 times upper limit of normal or less
- Urinary protein level of 2+ or less or 1000 mg/24 hours or less
- Negative pregnancy test for premenopausal women with childbearing potential within 7 days before treatment start and not lactating; all patients advised to use adequate contraception during treatment and for 6 months after
You will not qualify if you...
- Use of chemotherapy, biological therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose
- Use of mitomycin or nitrosoureas within 6 weeks before first dose
- Use of oral fluorouracil or palliative radiotherapy within 2 weeks before first dose
- Use of Chinese patent medicine within 2 weeks before first administration
- History of severe cardiovascular or cerebrovascular diseases
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Other malignant tumors diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two antihypertensive drugs
- History or suspicion of interstitial lung disease or grade 1 radiation pneumonitis
- Pulmonary disease grade 2 or higher causing significant respiratory impairment
- Poorly controlled blood sugar levels
- Active central nervous system metastases
- Massive, symptomatic, or poorly controlled effusions
- Tumor invasion or encasement of large blood vessels in chest, neck, or pharynx
- History of pulmonary embolism or thrombotic event needing treatment within 6 months before screening
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any BL-M05D1 ingredients
- Prior organ or allogeneic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m2 in previous therapy
- Positive for HIV antibodies, active tuberculosis, or active hepatitis B or C infection
- Active infection requiring systemic therapy
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or lactating women
- Investigator judgment against participation for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial cycle of 3 weeks; additional cycles possible depending on clinical benefit
Participants receive BL-M05D1 by intravenous infusion in cycles of 3 weeks. Those with clinical benefit may continue treatment for additional cycles until disease progression, intolerable toxicity, or other reasons lead to stopping.
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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