SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer

Sponsor
Tongji Hospital
Study ID
NCT06990516
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    Dose: 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg, administered intravenously (IV) every 3 weeks (Q3W). Infusion Duration: First infusion: 90 ± 10 minutes. Subsequent infusions: May be shortened to approximately 30 minutes (minimum 20 minutes, maximum 60 minutes, including flush phase) if no infusion-related reactions occur after the first dose.
  • Carboplatin — DRUG
    Dose: Area Under the Curve (AUC) 5 mg/mL/min, administered IV Q3W. Infusion Duration: Should be completed within 30-60 minutes (including flush phase). Treatment Schedule: Up to 6 treatment cycles, with each cycle lasting 3 weeks.
  • Oxaliplatin — DRUG
    Dose: 85 mg/m², administered IV Q3W. Infusion Duration: Should be infused over \>120 minutes (including flush phase). Treatment Schedule: Up to 6 treatment cycles, with each cycle lasting 3 weeks.
  • Bevacizumab — DRUG
    Dose: 15 mg/kg, administered IV Q3W. Infusion Duration: First dose: 90 minutes. Second dose: If the first infusion is well-tolerated, may be shortened to 60 minutes. Subsequent doses: If the 60-minute infusion is well-tolerated, all following infusions may be administered over 30 minutes (including flush phase).

Study Details

This study is a multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.

Key Dates

First listed
May 25, 2025
Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2035

Study Design

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

Arms

  • Experimental: SHR-A1811
    SHR-A1811: Administered at 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg intravenously every 3 weeks (Q3W). Carboplatin: Administered at an area under the concentration-time curve (AUC) of 5 mg/mL/min intravenously every 3 weeks (Q3W). Oxaliplatin: Administered at 85 mg/m² intravenously every 3 weeks (Q3W). Bevacizumab: Administered at 15 mg/kg intravenously every 3 weeks (Q3W). Treatment duration: Platinum - based drugs (carboplatin or oxaliplatin) will be administered for a maximum of 6 cycles or until the occurrence of any event meeting the protocol - defined criteria for treatment discontinuation, whichever occurs first. SHR-A1811 and bevacizumab will be continued until the occurrence of any event meeting the protocol - defined criteria for treatment discontinuation.

Primary Outcome Measure

Objective Response Rate (ORR): [ Time Frame: 5 Years after treatment. ]

Central Contacts

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