BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
- Conditions
- Cervical Cancer
- Interventions
- Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection
- Registration Number
- NCT06123884
- Lead Sponsor
- Bio-Thera Solutions
- Brief Summary
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
- Detailed Description
The single-arm Phase II exploratory study designed to evaluate the safety and efficacy of the study drug will include 20-50 subjects to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab. Dynamic analysis will be conducted after the inclusion of 20 subject. If the safety of this combination regimen is manageable and the efficacy meets expectations, the enrollment in the Phase II study will be stopped and the Phase III study will be entered. The Phase III study is a randomized, double-blind, multicenter clinical study of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab versus placebo plus platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. PFS and OS will be used as the combined endpoints, and a superiority design will be adopted with a total sample size of 476 subjects. Stratified block randomization will be performed based on the following random factors: patients will be stratified based on the presence of metastatic diseases at the time of diagnosis (Yes vs. No), PD-L1 CPS (1-10 vs. ≥ 10) and planned use of Bevacizumab (Yes vs. No).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 526
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAT1308 carboplatin Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 Bevacizumab Injection Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 Paclitaxel for Injection Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 monoclonal antibody Recombinant humanized anti-PD-1 monoclonal antibody injection Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 monoclonal antibody carboplatin Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 Recombinant humanized anti-PD-1 monoclonal antibody injection Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 monoclonal antibody Bevacizumab Injection Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 monoclonal antibody Paclitaxel for Injection Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 Cisplatin Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) BAT1308 monoclonal antibody Cisplatin Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) From first administration to the occurrence of objective tumor progression or all-cause death (whichever occurs first), the assessment period lasts up to two years. Tumor assessment is performed according to RECIST 1.1. Tumor imaging assessment is performed every 9 weeks (±7 days) after the first administration until week 54. After that, it is performed once every 12 weeks (±7 days) until disease progression, withdrawal from the group, loss to follow-up, death, or 24 months after the first study drug administration at the longest distance, whichever occurs first.
Overall Survival From the date of first administration to the time of death due to any cause, the assessment period will last up to two years. Tumor assessment is performed according to RECIST 1.1. Tumor imaging assessment is performed every 9 weeks (±7 days) after the first administration until week 54. After that, it is performed once every 12 weeks (±7 days) until disease progression, withdrawal from the group, loss to follow-up, death, or 24 months after the first study drug administration at the longest distance, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Vital signs Through study completion, an average of 2 years Number of cases with abnormal vital signs results
Adverse event Through study completion, an average of 2 years Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
Objective response rate (ORR) Through study completion, an average of 2 years The proportion of subjects whose tumors have shrunk by a certain amount and remained so for a certain period of time.
neutralizing antibody cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years. All subjects need to collect blood samples at specific time points during the treatment period. At each time point, about 4.0 mL of blood sample is planned to be collected to detect neutralizing antibody
Physical examination Through study completion, an average of 2 years Number of cases with abnormal physical examination results
Laboratory Examination Through study completion, an average of 2 years Number of cases with abnormal laboratory examination results
anti-drug antibodies cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years. All subjects need to collect blood samples at specific time points during the treatment period. At each time point, about 4.0 mL of blood sample is planned to be collected to detect anti-drug antibodies
Trial Locations
- Locations (1)
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China