Health TrialsbyHealthPanel

A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy

ConditionAdvanced Gynecological Malignancy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participate in the study voluntarily, sign the informed consent form.

Recurrent or metastatic gynecological malignancies that had failed standard treatments.

At least one measurable lesion (RECIST version 1.1).

ECOG 0~ 1.

Disqualifiers

With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.

Previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. Such as Cutaneous squamous cell carcinoma, cervical carcinoma in situ etc.

Had previously received antibody drug conjugates containing topoisomerase I inhibitors.

Had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A2102 for injection

    Drug

    SHR-A2102 for injection

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Assessed by Investigator according to RECIST 1.1 criteria.

Time frame
Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

Secondary outcomes

1

Duration of response (DoR)

Assessed by Investigator according to RECIST 1.1 criteria.

Time frame
Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
2

Disease control rate (DCR)

Assessed by Investigator according to RECIST 1.1 criteria.

Time frame
Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
3

Time to response (TTR)

Assessed by Investigator according to RECIST 1.1 criteria.

Time frame
Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
4

Progression free survival (PFS)

Assessed by Investigator according to RECIST 1.1 criteria.

Time frame
Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

Other outcomes

Sponsors and contacts

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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