drugset / Trial / NCT07407452

Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer

NCT07407452

Phase 2 Not yet recruiting 50 enrolled Jiangsu Cancer Institute & Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, open-label, multicenter Phase II clinical trial, planning to enroll 50 patients with advanced ovarian cancer. Enrolled participants will be assigned to 2 cohorts based on ECOG performance status and genetic mutation status: Cohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + paclitaxel (175 mg/m², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)/cisplatin (75 mg/m², Q3W, D1). Planned enrollment: 30 patients. Cohort 2: ECOG PS 2, BRCA1/2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg/m², Q3W, D1). Planned enrollment: 20 patients. Neoadjuvant therapy will be administered for 3 cycles, followed by patient status assessment. Patients with CR/PR/SD will be allowed to undergo surgery, while PD patients will have subsequent treatment strategies determined by the investigator.

Timeline

Start
2026-02-01
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown
Subject Carboplatin Small molecule 6 unknown
Subject Cisplatin Other / unclassified 75 mg/m2 Other
Subject Iparomlimab Monoclonal antibody 5 mg/kg
Subject Olaparib Small molecule 300 mg
Subject Paclitaxel Small molecule 175 mg/m2
Subject Tuvonralimab Monoclonal antibody 5 mg/kg

Indications