Actively Recruiting
A Study of BL-M08D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-14
22
Participants Needed
1
Research Sites
119 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, multicenter, dose-escalation and expansion-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M08D1 for injection in locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Study of BL-M08D1 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
- No gender restriction
- Age 18 years or older (up to 75 years for Phase Ia; no upper limit for Phase Ib)
- Expected survival of at least 3 months
- Confirmed locally advanced or metastatic solid tumors that are incurable or lack standard treatment
- Consent to provide archival or fresh tumor tissue samples within 2 years
- At least one measurable lesion as defined by RECIST v1.1
- ECOG performance status of 0 or 1
- Previous antitumor therapy toxicity resolved to grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- No blood transfusions or use of growth factors within 14 days before screening; adequate organ function
- Coagulation parameters: INR 1.5 or less, APTT 1.5 times upper limit or less
- Urinary protein level 2+ or less or 1000 mg/24h or less
- Negative pregnancy test within 7 days before treatment for premenopausal women with childbearing potential; not lactating
- Use of adequate barrier contraception during treatment and for 6 months after treatment end
- Ability and willingness to comply with all study visits, treatments, lab tests, and procedures
You will not qualify if you...
- Use of chemotherapy, biological therapy, or anti-tumor treatments within 4 weeks or 5 half-lives before first dose; mitomycin or nitrosoureas within 6 weeks; oral fluorouracil
- History of severe heart disease
- QT prolongation, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Diagnosis of other malignant tumors within 5 years before first dose
- Poorly controlled hypertension despite two antihypertensive drugs (systolic >150 mmHg or diastolic >100 mmHg)
- History or current interstitial lung disease requiring steroids or grade 2 or higher radiation pneumonitis
- Severe pulmonary diseases causing major respiratory impairment
- Symptoms of active central nervous system metastasis
- Allergy to recombinant humanized antibodies, human-mouse chimeric antibodies, or BL-M08D1 ingredients
- Previous organ or allogeneic hematopoietic stem cell transplantation
- HIV positive, active tuberculosis, active hepatitis B or C infections
- Active infection requiring systemic therapy within 4 weeks before first dose
- Pleural, abdominal, pelvic, or pericardial effusion requiring drainage or causing symptoms within 4 weeks before first dose
- Participation in another drug trial within 4 weeks or 5 half-lives before first dose
- Pregnant or lactating women
- Investigator's discretion for other reasons to exclude participation
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
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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