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

NCT07340164 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-04-20

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Trastzumab Deruxtecan

Trastzumab deruxtecan will be administrated via intravenous, every 3 weeks.

DRUG

Bevacizumab

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

DRUG

Platinum Based Chemotherapy

\*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

Sponsors & Collaborators

  • Daiichi Sankyo

    collaborator INDUSTRY

  • Boryung Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Entities

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340164 on ClinicalTrials.gov