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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
526
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
the usage and dosage should be determined by the investigator
Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGProgression-Free Survival (PFS)
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.
Time frame: 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.
Overall Survival
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.
Time frame: From the date of first administration to the time of death due to any cause, the assessment period will last up to two years.
Vital signs
Number of cases with abnormal vital signs results
Time frame: Through study completion, an average of 2 years
Physical examination
Number of cases with abnormal physical examination results
Time frame: Through study completion, an average of 2 years
Laboratory Examination
Number of cases with abnormal laboratory examination results
Time frame: Through study completion, an average of 2 years
Adverse event
Zhaohe Wang, Ph.D
CONTACT
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the usage and dosage should be determined by the investigator
the usage and dosage should be determined by the investigator
Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR)
The proportion of subjects whose tumors have shrunk by a certain amount and remained so for a certain period of time.
Time frame: Through study completion, an average of 2 years
anti-drug antibodies
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
Time frame: cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.
neutralizing antibody
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
Time frame: cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.