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A Study of SHR-A1811 in Subjects With Ovarian Cancer

ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily joined the study and signed the Informed consent forms (ICF).

Measurable disease, as defined by RECIST v1.1.

The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.

Life expectancy ≥ 12 weeks.

Disqualifiers

Symptomatic, untreated or active central nervous system metastases.

Have uncontrolled or severe cardiovascular disease.

With any active autoimmune disease or history of autoimmune disease.

Patients with active hepatitis B or hepatitis C.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811

    Drug

    SHR-A1811.

  • Paclitaxel Injection

    Drug

    Paclitaxel Injection.

  • Doxorubicin Hydrochloride Liposome Injection

    Drug

    Doxorubicin Hydrochloride Liposome Injection.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Gemcitabine Hydrochloride for Injection.

  • Topotecan Hydrochloride for Injection

    Drug

    Topotecan Hydrochloride for Injection.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: SHR-A1811 groupExperimental treatment 1 intervention
Group B: Chemotherapy groupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Time frame
From day 1 to 10 months.

Secondary outcomes

1

Objective response rate (ORR)

Time frame
From day 1 to 12 months.
2

Disease control rate (DCR)

Time frame
From day 1 to 12 months.
3

Duration of response (DOR)

Time frame
From day 1 to 12 months.
4

Overall survival (OS)

Time frame
From day 1 to 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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