Actively Recruiting
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-31
45
Participants Needed
1
Research Sites
132 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 expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M09D1 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 informed consent and follow the study protocol
- No gender restriction
- Age 18 years or older; up to 75 years for phase Ia
- Expected survival time of at least 3 months
- Pathologically or cytologically confirmed locally advanced or metastatic gastrointestinal tumors or other solid tumors that failed standard treatment
- Consent to provide tumor tissue samples within 2 years
- At least one measurable lesion as per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Toxicity from previous cancer therapy resolved to grade 1 or lower
- No severe cardiac dysfunction with left ventricular ejection fraction 50% or higher
- Organ functions meet study requirements
- Coagulation function with INR 1.5 or less and APTT 1.5 times upper limit of normal or less
- Urine protein level 2+ or less and 1000 mg/24 h or less
- Negative pregnancy test within 7 days before treatment for premenopausal women with childbearing potential; non-lactating
- Use of adequate barrier contraception during treatment and for 6 months after treatment end
- Able and willing to comply with study visits, treatment, and tests
You will not qualify if you...
- Anti-tumor therapy such as chemotherapy or biological therapy within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral fluorouracil
- History of severe heart disease
- QT prolongation, complete left bundle branch block, or third degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Unstable thrombotic events needing treatment within 6 months
- Poorly controlled hypertension
- Poorly controlled blood sugar
- History of interstitial lung disease needing steroids, current interstitial lung disease, or grade 2 or higher radiation pneumonitis
- Severe lung diseases causing serious breathing problems
- Active central nervous system metastasis symptoms
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any ingredients of BL-M09D1
- Prior organ or allogeneic stem cell transplantation
- Anthracycline cumulative dose over 360 mg/m2 in prior adjuvant therapy
- HIV positive, active tuberculosis, or active hepatitis B or C infection
- Active infection needing systemic therapy within 4 weeks or lung infection/inflammation within 2 weeks before first dose
- Effusions requiring drainage or causing symptoms within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks or 5 half-lives before first dose
- Pregnant or breastfeeding 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
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