Actively Recruiting
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-02-27
33
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 for Injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors 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
- No gender restrictions
- 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 digestive tract tumors or other solid tumors
- Agree to provide archived or fresh tumor tissue samples from primary or metastatic lesions within the past 3 years
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Toxicities from prior antitumor treatments recovered to Grade 1 or less as per NCI-CTCAE v5.0
- No severe cardiac dysfunction, left ventricular ejection fraction 50% or higher
- Organ function levels meet study requirements
- Coagulation function: INR 1.5 or less, APTT 1.5 times ULN or less
- Urine protein 2+ or less and 1000 mg/24h or less
- Premenopausal women with childbearing potential must have a negative pregnancy test within 7 days before treatment and not be breastfeeding
- All patients must use adequate barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks before first dose or within 5 half-lives
- 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 with two antihypertensive medications
- Poorly controlled blood glucose
- Unstable thrombotic events requiring treatment within 6 months before first dose
- Lung diseases graded 3 or higher by CTCAE v5.0
- Symptoms of active central nervous system metastases
- Allergy to recombinant humanized antibodies, human-mouse chimeric antibodies, or any BL-M24D1 excipients
- Previous organ or allogeneic hematopoietic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m² in previous therapy
- Positive for HIV antibody, active tuberculosis, or active hepatitis B or C infection
- History or current interstitial lung disease requiring steroid treatment
- Active infection requiring systemic treatment within 4 weeks before first dose
- Effusions requiring drainage or causing 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 the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing 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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