Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma
Phase II is a single-arm safety and efficacy study to explore the safety and initial efficacy of BAT1308 combined with platinum-containing chemotherapy. The first 6 patients (using 3+3 method) were included in the safe induction period, and 3 subjects were included first DLT assessment was performed. If there were less than 2 cases of DLT, 3 subjects were further included for DLT assessment Less than 2 cases of DLT in the total 6 cases were formally entered into the phase II study, if the phase II combination drug regimen was safe Phase II enrollment was stopped and phase III study was entered when the full treatment was controllable and the efficacy was in line with expectations. Phase I study is BAT1308 in combination with platinum-containing chemotherapy vs. placebo plus platinum-containing chemotherapy for advanced first-line treatment or A randomized, double-blind, multicenter clinical study of patients with recurrent dMMR endometrial cancer. PFS As the primary endpoint, optimal design. Stratified by the following random factors Histological randomization: according to disease status (stage III, IV, or relapse), prior pelvic extrinsic release Patients were stratified by treatment history (yes or no).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
the usage and dosage should be determined by the investigator
the usage and dosage should be determined by the investigator
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
vital signs
Number of participants with abnormal vital signs
Time frame: Through study completion, 1 year
Physical examination
Number of participants with abnormal physical examination
Time frame: Through study completion, 1 year
Adverse events
Number of participants with various adverse events (AEs)
Time frame: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier,assessed up to 1 year
Clinical laboratory tests
Number of participants with abnormal clinical laboratory tests
Time frame: Through study completion, 1 year
Clinical auxiliary tests
Number of participants with abnormal clinical auxiliary tests
Time frame: Through study completion, 1 year
Dose-limiting toxicity (DLT)
DLT events and their incidence
Time frame: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy,assessed up to 1 year
Progression Free Survival
Progression Free Survival(PFS )in patients with advanced or recurrent dMMR endometrial cancer treated with BAT1308 combined with platinum-containing chemotherapy were compared with platinum-containing chemotherapy in first-line treatment by IRC according to RECIST V1.1.
Time frame: Tumor imaging assessments will be performed once every 6 (±7) days during the screening period, once every 6 (±7) days after initial dosing to 25 weeks, and once every 9 (±7) weeks,assessed up to 1 year,the screening period is 28 days
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Initial efficacy
Initial efficacy was assessed by investigators according to the solid tumor Efficacy Evaluation Criteria (RECIST V1.1)
Time frame: Tumor imaging assessments will be performed once every 6 (±7) days during the screening period, once every 6 (±7) days after initial dosing to 25 weeks, and once every 9 (±7) weeks,assessed up to 1 year
Pharmacokinetic
Level of Cmax
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks,assessed up to 1 year,each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Level of Tmax
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks,assessed up to 1 year,each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Level of T1/2
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks,assessed up to 1 year,each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Level of CL
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks,assessed up to 1 year,each cycle is 28 days(The first 12 subjects).
Immunogenicity
Level of ADA
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks,assessed up to 1 year,each cycle is 28 days
Immunogenicity
Level of NAb
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks,assessed up to 1 year,each cycle is 28 days