Actively Recruiting
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-12-31
16
Participants Needed
1
Research Sites
98 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 head and neck squamous cell carcinoma and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with the protocol requirements
- Gender unrestricted
- Age 18 to 75 years (Phase Ia), 18 years and older (Phase Ib)
- Expected survival time of at least 3 months
- Diagnosis of locally advanced or metastatic head and neck squamous cell carcinoma or other solid tumors
- Agree to provide archived or fresh tumor tissue samples within the past 3 years
- Have at least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Toxicities from prior antitumor therapy recovered to Grade 1 or less per NCI-CTCAE v5.0
- No severe cardiac dysfunction with left ventricular ejection fraction 50% or higher
- Meet required organ function levels
- Coagulation function: INR 1.5 or less and aPTT 1.5 times ULN or less
- Urine protein 2+ or less or 1000 mg/24h or less
- For premenopausal women with childbearing potential, negative serum pregnancy test within 7 days before treatment start and not lactating
- Use adequate barrier contraception during treatment and for 6 months after
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 before first dose
- Poorly controlled hypertension despite two antihypertensive medications
- Poorly controlled blood glucose levels
- Unstable thrombotic events needing treatment within 6 months before first dose
- Lung disease graded 3 or higher per CTCAE v5.0
- Symptoms of active central nervous system metastasis
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any BL-M24D1 excipient
- Previous organ transplant or allogeneic hematopoietic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m2 during prior anthracycline therapy
- Positive for HIV antibody, active tuberculosis, active hepatitis B or C infection
- History of interstitial lung disease requiring steroids or current ILD
- Active infection requiring systemic treatment within 4 weeks before first dose or lung infection within 2 weeks
- Effusions requiring drainage or symptoms within 4 weeks before first dose
- 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 investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, 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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here