Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT07776171
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Rezetecan (SHR-A1811) — DRUG
    Administered intravenously on Day 1 of each 3-week treatment cycle.
  • Carboplatin — DRUG
    Administered intravenously on Day 1 of each 3-week treatment cycle.
  • Bevacizumab — DRUG
    Administered intravenously on Day 1 of each 3-week treatment cycle.
  • Bevacizumab — DRUG
    Administered intravenously.
  • Carboplatin + Paclitaxel — DRUG
    Administered intravenously.
  • Carboplatin + pegylated liposomal doxorubicin — DRUG
    Administered intravenously.
  • Carboplatin + Gemcitabine — DRUG
    Administered intravenously

Study Details

This study is a randomized, open-label, controlled phase II clinical trial. It is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi). Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).

Key Dates

First listed
Aug 20, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 30, 2028
Completion
May 30, 2030

Study Design

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

Arms

  • Experimental: Trastuzumab rezetecan + Carboplatin ± Bevacizumab
    Participants will receive trastuzumab rezetecan + carboplatin ± bevacizumab once every 3 weeks (Q3W).
  • Active Comparator: Investigator Choice of Chemotherapy ± Bevacizumab
    Participants will receive carboplatin plus paclitaxel ± bevacizumab, carboplatin plus gemcitabine ± bevacizumab, , or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]

Central Contacts

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