Actively Recruiting
A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21
96
Participants Needed
1
Research Sites
118 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 trial to evaluate the efficacy and safety of BL-B01D1 + pembrolizumab dual therapy with or without bevacizumab (BL-B01D1 + pembrolizumab ± bevacizumab) in patients with recurrent or metastatic cervical cancer and endometrial cancer.
CONDITIONS
Official Title
A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers aged 18 to 75 years who sign informed consent
- Expected survival of at least 3 months
- ECOG performance status score of 0 to 1
- Diagnosed with recurrent or metastatic cervical or endometrial cancer confirmed by histopathology or cytology
- Provide archived tumor tissue samples from the past 3 years for testing
- Have at least one measurable tumor lesion as defined by RECIST v1.1
- Adequate organ function
- Recovery from prior anti-tumor therapy toxicities to Grade 1 or less
- For premenopausal women with childbearing potential: negative pregnancy test within 7 days before treatment start, not breastfeeding, and use adequate barrier contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Previous treatment with ADC drugs containing topoisomerase I inhibitors or targeting EGFR/HER3
- Chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives before first dose
- For Stage II (except Cohort 1), previous systemic anti-tumor therapy
- Prior immunotherapy causing Grade 3 or higher immune-related adverse events or Grade 2 or higher myocarditis
- Use of immunomodulatory drugs within 14 days before first dose
- Systemic corticosteroid therapy within 2 weeks before first dose
- History of severe cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases
- Other cancers progressing or treated within 3 years before first dose
- History or presence of interstitial lung disease/pneumonitis requiring steroids or currently active
- Poorly controlled hypertension requiring two or more medications
- Poorly controlled diabetes
- Unstable thrombotic events needing treatment within 6 months before screening
- Active central nervous system metastases
- Significant or poorly controlled serous cavity effusions
- Allergy to recombinant humanized antibodies or study drug components
- Prior organ or stem cell transplantation
- Positive for HIV, active tuberculosis, hepatitis B or C infections
- Active infections needing systemic treatment
- Participation in another clinical trial within 4 weeks before first dose
- Imaging showing tumor invasion or encasement of major blood vessels
- Severe unhealed wounds, ulcers, or fractures within 4 weeks before consent
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Planned or recent live vaccines within 28 days before randomization
- Severe neurological or psychiatric disorders
- Other conditions judged unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 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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