Actively Recruiting
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
130
Participants Needed
1
Research Sites
212 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
Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.
CONDITIONS
Official Title
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years
- Signed informed consent to participate
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Diagnosis of recurrent or metastatic cervical cancer or other gynecological malignancies confirmed by histopathology or cytology after failure or intolerance to standard treatment or no standard treatment available
- Willingness to provide 10 surgical specimens or fresh tumor tissue samples collected within the past 3 years
- At least one measurable lesion as defined by RECIST v1.1
- No blood transfusion, colony-stimulating factor, cell growth factor injection, or albumin injection within 14 days before first study drug use
- Urine protein level of 2+ or less or ≤1000g/24h
- No severe cardiac dysfunction with left ventricular ejection fraction ≥50%
- Toxicity from prior anti-cancer therapy returned to grade 1 or lower per NCI-CTCAE v5.0
- For premenopausal women with childbearing potential, a negative pregnancy test within 7 days before treatment start, not lactating, and agreement to use adequate barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Prior treatment with antibody-drug conjugate (ADC) drugs containing topoisomerase I inhibitors
- Use of antineoplastic therapy within 4 weeks or 5 half-lives before first dose; mitomycin or nitrosoureas within 6 weeks; oral fluorouracil or palliative radiotherapy within 2 weeks before first dose
- History of grade 3 or higher immune-related adverse events (irAE) or grade 2 or higher immune-related myocarditis in certain cohorts
- Immunomodulatory drug use within 14 days before first study drug dose in certain cohorts
- History of serious cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases
- Other malignant tumors progressing or requiring treatment within 5 years before first dose
- History or suspicion of interstitial lung disease (ILD) requiring steroid therapy or current ILD
- Poorly controlled diabetes, hypertension, hypertensive crisis, or hypertensive encephalopathy before first medication
- New deep vein thrombosis within 14 days or pulmonary embolism within 6 months
- Active central nervous system metastases
- Massive, symptomatic, poorly controlled, or unstable effusions
- Allergy to recombinant humanized antibody, human-mouse chimeric antibody, or any component of BL-B01D1
- Prior organ or allogeneic hematopoietic stem cell transplantation
- Positive HIV antibody, active tuberculosis, active hepatitis B or C infection
- Active infections requiring systemic treatment such as severe pneumonia, bacteremia, or sepsis
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic drug abuse or mental disorders preventing cessation
- History of intestinal obstruction within 6 months before screening
- Other conditions deemed inappropriate 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
Cancer Hospital Chinese Academy of Medical Sciences
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