Actively Recruiting
BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
Led by Bio-Thera Solutions · Updated on 2025-02-10
526
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer
CONDITIONS
Official Title
BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years who voluntarily sign informed consent
- Persistent, recurrent, or metastatic cervical cancer confirmed by pathology, including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, or clear-cell renal-cell carcinoma, not suitable for radical surgery or radiotherapy
- Positive PD-L1 expression (CPS ≥ 1) in tumor tissue confirmed by central laboratory with adequate specimens
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Life expectancy of at least 12 weeks
- ECOG Performance Status score of 0 or 1
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during the study until 6 months after last dose; postmenopausal women must have amenorrhea for at least 12 months
- Able to understand and comply with trial procedures
You will not qualify if you...
- Other pathological types of cervical cancer such as small cell carcinoma or sarcoma
- Pregnant or lactating women
- Radiotherapy within 14 days before first dose, except limited palliative radiotherapy
- Prior use of chemotherapeutic agents to sensitize radiotherapy within 14 days before first dose
- Use of traditional Chinese patent medicines or anti-tumor Chinese herbal medicines within 14 days before first dose
- Receipt of live/attenuated or mRNA vaccines within 4 weeks prior to screening or planned during study
- Prior treatments targeting tumor immunity mechanisms such as immune checkpoint inhibitors
- Adverse events from prior anti-tumor therapy greater than Grade 1 except stable alopecia or fatigue
- Active leptomeningeal disease or uncontrolled brain metastases
- Major surgery or significant trauma within 4 weeks before first dose
- Serious infections within 4 weeks before first dose
- Active infections including HIV, hepatitis B or C, or syphilis
- Untreated or active tuberculosis
- History of severe allergy to monoclonal antibodies or investigational drug components
- Contraindications or allergies to cisplatin, carboplatin, or paclitaxel
- Clinically significant hydronephrosis not relieved by intervention
- Uncontrollable pleural, pericardial effusion, or ascites requiring repeated drainage
- Active or recurrent autoimmune disease except certain controlled conditions
- Systemic glucocorticoid or immunosuppressive treatment within 14 days before first dose except specific exceptions
- History of noninfectious pneumonitis requiring glucocorticoids within 1 year or current interstitial lung disease
- Severe cardiovascular or cerebrovascular disorders including heart failure, arrhythmias, recent acute coronary syndrome, or uncontrolled hypertension
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
J
Juan Chen
CONTACT
Z
Zhaohe Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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