Health TrialsbyHealthPanel

A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

ConditionGynaecological Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily joined the study and signed the 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.

Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..

Have uncontrolled or severe cardiovascular disease.

With any active autoimmune disease or history of autoimmune disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR- A1811

    Drug

    Subjects with gynaecological malignancies

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: Treatment group with SHR-A1811Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
12 months

Secondary outcomes

1

Progression free survival (PFS)

Time frame
12 months
2

Objective response rate (ORR)

Time frame
12 months
3

Disease control rate (DCR)

Time frame
12 months
4

Duration of response (DOR)

Time frame
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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