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

Sponsor
Yonsei University
Study ID
NCT07340164
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ovarian Cancer
  • Ovarian Cancer (OvCa)
  • Ovarian Cancer Metastatic Recurrent
  • Ovarian Carcinoma, Recurrent

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastzumab Deruxtecan — DRUG
    Trastzumab deruxtecan will be administrated via intravenous, every 3 weeks.
  • Bevacizumab — DRUG
    Bevacizumab is administered intravenously in one of two doses: 1. 10 mg/kg every 2 weeks 2. 15 mg/kg every 3 weeks 1. 10mg/kg, every 2weeks 2. 15mg/kg, every 3weeks
  • Platinum Based Chemotherapy — DRUG
    \*Proposed regimens for Arm B 1. PLD 30\~40mg/m2 D1 + Carboplatin AUC 5 D1 +/- bevacizumab 10mg/kg D1/D15 q4w (for 6-8 cycles) followed by bevacizumab 15mg/kg q3w 2. Paclitaxel 175mg/m2 D1 + Carboplatin AUC 5 D1 +/- bevacizumab 15mg/kg D1 q3w (for 6-8 cycles) followed by bevacizumab 15mg/kg q3w 3. Gemcitabine 1000mg/m2 D1/D8 + Carboplatin AUC 4 or 5 D1 +/- bevacizumab 15mg/kg D1 q3w (for 6-8 cycles) followed by bevacizumab 15mg/kg q3w

Study Details

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

Key Dates

First listed
Jan 14, 2026
Start date
Feb 26, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Arm A
    Trastzumab Deruxtecan(T-DXd) +/- Bevacizumab
  • Active Comparator: Arm B
    Platinum based chemotherapy +/- Bevacizumab

Primary Outcome Measure

Progression Free Survival (PFS) in HER2 IHC 1+/2+/3+ population [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years. ]

Central Contacts

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