Clinical Trials Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT07779538
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • trastuzumab — DRUG
    trastuzumab
  • bevacizumab — DRUG
    bevacizumab

Study Details

This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2030
Completion
May 30, 2030

Study Design

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

Arms

  • Experimental: Treatment group A
  • Other: Treatment group B

Primary Outcome Measure

Dose limited toxicity (DLT) [ Time Frame: up to 21 days ]

Central Contacts

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