Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-18
22
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-M14D1 in people with locally advanced or metastatic small cell lung cancer, neuroendocrine tumors, and other solid tumors that cannot be cured or lack standard treatment options. This open, multicenter, phase I clinical study aims to assess the safety, tolerability, how the drug moves through the body (pharmacokinetics), and early signs of effectiveness of BL-M14D1 in these patients. Participants receive BL-M14D1 through an intravenous infusion over a 3-week cycle. Those who show clinical benefit may continue treatment for additional cycles until disease progression, unacceptable side effects, or other reasons require stopping. The study includes dose escalation and expansion stages to determine appropriate dosing and safety. During the study, participants will be monitored for side effects, blood levels of the drug, immune reactions, and tumor response using clinical and imaging assessments. Researchers will measure outcomes such as dose-limiting toxicity, maximum tolerated dose, objective response rate, disease control rate, and duration of response. Follow-up and safety evaluations may continue for up to 24 months from the first dose.
CONDITIONS
Brief Title
A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years (stage Ia) or 18 years and older (stage Ib)
- Voluntarily sign informed consent and agree to follow the study protocol
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors without curative or standard treatment options
- Consent to provide tumor tissue samples from the past 2 years
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Previous antitumor therapy toxicity returned to grade 1 or less
- No severe cardiac dysfunction, with left ventricular ejection fraction of 50% or higher
- Adequate organ function without recent blood transfusion or growth factor drugs
- Coagulation function with INR of 1.5 or less and APTT within 1.5 times upper limit
- Urine protein level +2 or less, or 1000 mg/24 h or less
- For premenopausal women, negative pregnancy test within 7 days before treatment and not lactating
- Use of effective contraception during treatment and for 6 months after
You will not qualify if you...
- Received chemotherapy or biological therapy within 4 weeks or 5 half-lives before first dose; mitomycin or nitrosoureas within 6 weeks; oral fluorouracil drugs
- Previous treatment with an antibody-drug conjugate using TOPI inhibitor toxin
- History of severe heart or cerebrovascular disease
- QT prolongation, complete left bundle branch block, third-degree atrioventricular block, or uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two medications
- History or signs of interstitial lung disease or significant radiation pneumonitis
- Severe respiratory conditions or uncontrolled effusions
- Tumor invasion of major blood vessels in chest, neck, or pharynx
- Unstable thrombotic events in past 6 months
- Active central nervous system metastases symptoms
- Allergy to recombinant humanized or human-mouse chimeric antibodies or BL-M14D1 ingredients
- Prior organ or stem cell transplantation
- High cumulative anthracycline dose over 360 mg/m2
- Positive HIV, active tuberculosis, or active hepatitis B or C infections
- Active serious infections within 4 weeks or pulmonary infections within 2 weeks before consent
- Participation in another clinical trial within 4 weeks before first dose
- Pregnant or lactating women
- Severe neurological or psychiatric illness history
- Recent severe wounds, ulcers, fractures, or bleeding issues
- History of intestinal obstruction, inflammatory bowel disease, or extensive bowel surgery
- Planned vaccination or live vaccine within 28 days before first dose
- Other conditions deemed inappropriate by investigators
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.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-M14D1 as an intravenous infusion for a cycle of 3 weeks. Those with clinical benefit may receive additional treatment cycles until disease progression, intolerable toxicity, or other reasons for stopping.
1 visit per treatment cycle (in-person)
Duration - Up to approximately 24 months
Participants are monitored for safety, pharmacokinetics, and preliminary efficacy for up to approximately 24 months after starting treatment.
Regular visits during follow-up period
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai 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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