Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Cisplatin

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).

Recombinant humanized anti-PD-1 monoclonal antibody injection

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)

Bevacizumab Injection

carboplatin

Paclitaxel for Injection

Juan Chen

Zhaohe Wang, Ph.D

Qinglei Gao, Ph.D

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).

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

A Phase II/III 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

Safety endpoints: Number of participants with abnormal vital signs

Safety endpoints: Number of participants with abnormal physical examination

Safety endpoints: Number of participants with various adverse events (AEs)

Safety endpoints: Number of participants with abnormal clinical laboratory tests

Safety endpoints: Number of participants with abnormal clinical auxiliary tests

Preliminary efficacy of the participants which is evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1)

Preliminary efficacy of the participants which is evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1).

Safety endpoints: Number of participants with abnormal various adverse events (AEs)

Safety endpoints:Number of participants with abnormal clinical auxiliary tests

Spots Global Cancer Trial Database for paclitaxel for injection