Actively Recruiting
A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
376
Participants Needed
1
Research Sites
210 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 phase II study is a clinical study to explore the efficacy and safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors.
CONDITIONS
Official Title
A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign informed consent and follow study rules
- No gender restriction
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Diagnosis of locally advanced or metastatic esophageal, gastric, colorectal cancer or other gastrointestinal tumors
- Agree to provide archived or fresh tumor tissue samples within the last 2 years
- Have at least one measurable tumor lesion as defined by RECIST v1.1
- ECOG performance status 0 or 1
- Toxicity from previous anticancer treatments must have resolved to grade 1 or less
- No severe heart dysfunction; left ventricular ejection fraction 50% or above
- No blood transfusion or use of growth factors within 14 days before screening; organ function must meet criteria
- Blood clotting times within defined limits (INR ≤1.5; activated clotting time ≤1.5 times upper limit)
- Urinary protein level 2+ or less, or less than 1000 mg per 24 hours
- Premenopausal women with childbearing potential must have negative pregnancy test within 7 days before treatment start and not be breastfeeding
- All patients advised to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Antitumor therapy like chemotherapy or biologics within 4 weeks or 5 half-lives before study start; mitomycin and nitrosoureas within 6 weeks; certain oral drugs
- Prior treatment with ADC drugs containing topoisomerase I inhibitors if using BL-B01D1
- Use of immunomodulatory drugs or systemic corticosteroids within 2 weeks before study start
- History of severe immune-related side effects from immunotherapy
- History of severe heart disease or certain heart conduction abnormalities
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before study start
- Poorly controlled diabetes, hypertension, or history of hypertensive crises
- Severe pulmonary disease or interstitial lung disease
- Recent unstable blood clots needing treatment
- Unstable effusions in body cavities
- Active brain metastases
- Allergies to study drugs or components
- Prior organ or stem cell transplant
- Positive for HIV or active serious infections like tuberculosis or hepatitis
- Active infections requiring systemic treatment
- Participation in another clinical trial within 4 weeks before study
- Received live vaccines within 4 weeks before study
- History of mental illness or drug abuse preventing trial cooperation
- Other investigator-determined reasons making participation inappropriate
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
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