A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT06840002
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • SHR-A1811 — DRUG
    SHR-A1811.
  • Carboplatin — DRUG
    Carboplatin.
  • Bevacizumab — DRUG
    Bevacizumab.
  • Oxaliplatin for Injection — DRUG
    Oxaliplatin for injection.
  • Paclitaxel injection — DRUG
    Paclitaxel injection.
  • Doxorubicin hydrochloride liposome injection — DRUG
    Doxorubicin hydrochloride liposome injetction.
  • Adebrelimab Injection — DRUG
    Adebrelimab injection.

Study Details

The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.

Key Dates

First listed
Feb 21, 2025
Start date
Mar 18, 2025
Status verified
Apr 2025
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group

Primary Outcome Measure

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

Central Contacts

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