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

Sponsor
Bio-Thera Solutions
Study ID
NCT06123884
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Recombinant humanized anti-PD-1 monoclonal antibody injection — DRUG
    Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
  • Cisplatin — DRUG
    the usage and dosage should be determined by the investigator
  • Bevacizumab Injection — DRUG
    Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)
  • carboplatin — DRUG
    the usage and dosage should be determined by the investigator
  • Paclitaxel for Injection — DRUG
    the usage and dosage should be determined by the investigator

Study Details

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

Key Dates

First listed
Nov 9, 2023
Start date
Dec 13, 2023
Status verified
Feb 2025
Primary completion
Sep 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
526 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAT1308
    Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
  • Placebo Comparator: BAT1308 monoclonal antibody
    Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)

Primary Outcome Measure

Progression-Free Survival (PFS) [ 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. ]

Central Contacts

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