NCT06321068

BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer

Phase II/III Study of the Safety and Efficacy of BAT1308 in Combination With Platinum-containing Chemotherapy for First-line Treatment of Advanced or Recurrent Mismatch Repair Protein-deficient (dMMR) Endometrial Cancer

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	the usage and dosage should be determined by the investigator
DRUG	Paclitaxel	the usage and dosage should be determined by the investigator
DRUG	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).

Timeline

• Start date: 2024-04-09
• Primary completion: 2025-05-30
• Completion: 2025-08-07
• First posted: 2024-03-20
• Last updated: 2025-08-14

Locations

1 site across 1 country: China