Actively Recruiting
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-18
20
Participants Needed
1
Research Sites
105 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-M17D1 in locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancer and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study requirements
- No gender restriction
- Age 18 to 75 years for stage Ia; age 18 years and older for stage Ib
- Expected survival time of at least 3 months
- Confirmed diagnosis of locally advanced or metastatic HER2 positive or low expression digestive tract tumor or other solid tumor
- Consent to provide archival or fresh tumor tissue samples within 2 years
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Toxicities from prior cancer treatments have resolved to grade 1 or less per NCI-CTCAE v5.0
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- Organ function meets study requirements
- Coagulation function with international normalized ratio 1.5 or less and activated partial thromboplastin time 1.5 times upper limit of normal or less
- Urine protein level 2+ or less or 1000 mg/24h or less
- Premenopausal women with childbearing potential must have negative pregnancy test within 7 days before treatment and not be lactating
- All patients must use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Anti-tumor therapy including chemotherapy or biological therapy within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; certain oral drugs such as fluorouracil
- History of severe heart disease
- QT prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmias
- Active autoimmune or inflammatory diseases
- Other malignant tumors diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two antihypertensive drugs
- Poor glycemic control before first dose
- Interstitial lung disease or current suspected ILD
- Severe respiratory impairment due to lung diseases
- Massive or symptomatic effusions or poorly controlled effusions
- Tumor invasion or encasement of major blood vessels in chest, neck, or pharynx
- Unstable thrombotic events needing treatment within prior 6 months
- Active central nervous system metastases
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any BL-M17D1 components
- Prior organ or allogeneic hematopoietic stem cell transplantation
- Positive HIV antibody, active tuberculosis, or active hepatitis B or C infection
- Active serious infection requiring systemic therapy within 4 weeks
- Pulmonary infection or inflammation within 2 weeks
- Participation in another clinical trial within 4 weeks
- Pregnant or lactating women
- Superior vena cava syndrome
- Severe neurological or psychiatric illness history
- Severe unhealed wounds, ulcers, or fractures within 4 weeks
- Significant bleeding or bleeding tendency within 4 weeks
- History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Scheduled for vaccination or receiving live vaccine within 28 days before first dose
- Other conditions deemed inappropriate by 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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