SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT06859775
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Recurrent or Metastatic Cervical Cancer

Eligibility Criteria

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

Interventions

  • SHR-A1811 — DRUG
    SHR-A1811 injection.
  • Adebelimab injection — DRUG
    Adebelimab injection.
  • Bevacizumab injection — DRUG
    Bevacizumab injection.
  • SHR-8068 — DRUG
    SHR-8068 injection.
  • Cisplatin injection — DRUG
    Cisplatin injection.
  • Carboplatin injection — DRUG
    Carboplatin injection.

Study Details

This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.

Key Dates

First listed
Mar 5, 2025
Start date
Apr 25, 2025
Status verified
Jun 2025
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment cohort 1
  • Experimental: Treatment cohort 2
  • Experimental: Treatment cohort 3

Primary Outcome Measure

Grade≥3 drug-related adverse events (TRAEs). [ Time Frame: Up to 3 years. ]

Central Contacts