drugset / Trial / NCT07340164

Trastzumab Deruxtecan Versus SOC in Recurrent Ovarian That Progressed on Prior PARP Inhibitor Therapy

NCT07340164

RandomizedParallel-groupOpen-labelTreatment

Summary

Ovarian, fallopian tube, and peritoneal cancers are often diagnosed at an advanced stage, requiring chemotherapy. Recently, the standard treatment, platinum-based chemotherapy plus PARP inhibitors, has extended disease-free survival (PFS). However, most patients eventually develop resistance to PARP inhibitors and become unresponsive to conventional treatments. Therefore, an effective standard treatment for patients who relapse after PARP inhibitor resistance has not yet been established. Meanwhile, HER2 protein expression has been identified in some patients, drawing attention as a new therapeutic target. Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate (ADC) targeting HER2, has already demonstrated efficacy and safety in other HER2-positive cancers. This study aimed to explore the potential of T-DXd as a new treatment option by evaluating the efficacy and safety of T-DXd in patients with ovarian, fallopian tube, and peritoneal cancer who relapsed after PARP inhibitor treatment and who express HER2. Participants will: * Arm A: T-DXd +/- Bevacizumab, IV, every 3weeks * Arm B: Platinum-based chemotherapy +/- Bevacizumab, IV

Timeline

Start
2026-02-26
Primary completion
2026-12-30
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 4 unknown
Comparator Carboplatin Small molecule 5 unknown
Comparator PLD Unknown 30 mg/m2
Comparator PLD Unknown 40 mg/m2
Subject Trastuzumab deruxtecan Monoclonal antibody Intravenous
Background Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous

Indications