Actively Recruiting
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-11-24
33
Participants Needed
1
Research Sites
107 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, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with protocol requirements
- All genders allowed
- Age 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected survival time of at least 3 months
- Diagnosis of locally advanced or metastatic non-small cell lung cancer or other solid tumors
- Agree to provide archived or fresh tumor tissue samples from the past 3 years
- Must have at least one measurable lesion meeting RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Toxicities from prior antitumor therapy recovered to Grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- Organ function meeting study requirements
- Coagulation function: INR 1.5 or less, and activated partial thromboplastin time 1.5 times upper limit of normal or less
- Urine protein 2+ or less, or 1000mg/24h or less
- Premenopausal women with childbearing potential must have negative pregnancy test within 7 days before treatment and not be breastfeeding
- All participants must use adequate barrier contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives before first dose
- History of severe heart disease
- QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Diagnosis of other malignancies within 5 years prior to first dose
- Hypertension poorly controlled by two antihypertensive medications
- Poorly controlled blood glucose
- Unstable thrombotic events needing treatment within 6 months before first dose
- Lung diseases grade 3 or higher
- Symptoms of active central nervous system metastasis
- Allergy to recombinant humanized antibodies, human-mouse chimeric antibodies, or BL-M24D1 excipients
- Previous organ or allogeneic hematopoietic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m2 in prior therapy
- Positive HIV antibody, active tuberculosis, active hepatitis B or C infection
- History or current interstitial lung disease needing hormonal treatment
- Active infection needing systemic treatment within 4 weeks before first dose
- Effusion requiring drainage or with symptoms within 4 weeks before first dose
- Clinically significant bleeding or bleeding tendency within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or lactating women
- Other conditions deemed 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 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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