BAT1308 Combined With Platinum-Based Chemotherapy± Bevacizumab For PDL1-Positive (CPS ≥1) Cervical Cancer

Phase 2

Not yet recruiting

• Conditions: Cervical Cancer
• Interventions: Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection; Drug: Cisplatin; Drug: Bevacizumab Injection; Drug: carboplatin; Drug: Paclitaxel for 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).

Study Timeline

• Study First Submitted: 2023-09-21
• Status Verified: 2023-11
• Study Start: 2023-11
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-04
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 526

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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
Phase III study Primary endpoints:	Eevery 9 weeks during treatment from randomization up to Week 54, After week54 is every 12 weeks.	Preliminary efficacy of the participants which is evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Phase II study Primary endpoints:	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	Safety endpoints: Number of participants with abnormal clinical auxiliary tests

Secondary Outcome Measures

Name	Time	Method
Phase II study Secondary endpoints:	Eevery 9 weeks during treatment from randomization up to Week 54, After week54 is every 12 weeks	Preliminary efficacy of the participants which is evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1).
Number of participants after single dose and multiple doses to PK characteristics evaluation	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle1Day2,Cycle1Day3,Cycle1Day8,Cycle1Day15,Cycle2Day1,Cycle3Day1,Cycle3Day2,Cycle3Day3,Cycle3Day8,Cycle4Day1,Cycle5Day1,Cycle6Day1, after Cycle6, per 9 weeks.	Vd
Number of participants after single dose and multiple dose to data point evaluation	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle1Day2,Cycle1Day3,Cycle1Day8,Cycle1Day15,Cycle2Day1,Cycle3Day1,Cycle3Day2,Cycle3Day3,Cycle3Day8,Cycle4Day1,Cycle5Day1,Cycle6Day1, after Cycle6, per 9 weeks.	AUC(0-τ)
Number of participants after single dose and multiple dose to Peak plasma concentration evaluation	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle1Day2,Cycle1Day3,Cycle1Day8,Cycle1Day15,Cycle2Day1,Cycle3Day1,Cycle3Day2,Cycle3Day3,Cycle3Day8,Cycle4Day1,Cycle5Day1,Cycle6Day1, after Cycle6, per 9 weeks.	Cmax
Number of participants after single dose and multiple dose to Immunogenicity evaluation when the ADA is positive.	At the end of Cycle 1 (each cycle is 21 days),Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle6, per 9 weeks.	neutralizing antibodies (NAbs)
Number of participants after single dose and multiple dose to area under the drug concentration-time curve evaluation	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle1Day2,Cycle1Day3,Cycle1Day8,Cycle1Day15,Cycle2Day1,Cycle3Day1,Cycle3Day2,Cycle3Day3,Cycle3Day8,Cycle4Day1,Cycle5Day1,Cycle6Day1, after Cycle6, per 9 weeks.	AUC(0-∞)
Number of participants after single dose and multiple doses to immunogenicity evaluation.	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle3Day1,Cycle5Day1,after Cycle6, per 9 weeks.	Anti-drug antibodies (ADAs)
Number of participants after single dose and multiple dose to PK characteristics evaluation	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle1Day2,Cycle1Day3,Cycle1Day8,Cycle1Day15,Cycle2Day1,Cycle3Day1,Cycle3Day2,Cycle3Day3,Cycle3Day8,Cycle4Day1,Cycle5Day1,Cycle6Day1, after Cycle6, per 9 weeks.	T1/2
Number of participants after single dose and multiple doses to PK characteristics	At the Day of Cycle 1 (each Cycle is 21 Days),Cycle1Day1,Cycle1Day2,Cycle1Day3,Cycle1Day8,Cycle1Day15,Cycle2Day1,Cycle3Day1,Cycle3Day2,Cycle3Day3,Cycle3Day8,Cycle4Day1,Cycle5Day1,Cycle6Day1, after Cycle6, per 9 weeks.	CL
Phase III study Secondary endpoints:	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	Safety endpoints:Number of participants with abnormal clinical auxiliary tests
Number of participants after single dose and multiple dose to immunogenicity evaluation.	At the end of Cycle 1 (each cycle is 21 days),Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle6, per 9 weeks.	Anti-drug antibodies (ADAs)

Trial Locations

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology; 🇨🇳 Wuhan, Hubei, China