Recruiting NCT06654440

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

Phase II Interventional Advanced Gynecological Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: SHR-A2102 for injection.
Who it may be relevant to: Registry conditions: Advanced Gynecological Malignancy. Basic parameters: 18 years — 75 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies

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

Objective Response Rate (ORR) [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 outcome measures (11)

Duration of response (DoR) [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.]
Disease control rate (DCR) [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.]
Time to response (TTR) [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.]
Progression free survival (PFS) [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.]
Overall survival (OS) [Time frame: follow up once every 60 days. Up to approximately 36 months.]
12 month survival rate [Time frame: follow up once every 60 days. Up to approximately 24 months.]
Adverse Events (AEs) [Time frame: Up to approximately 24 months.]
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102. [Time frame: Up to approximately 24 months.]
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites. [Time frame: Up to approximately 24 months.]
ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. [Time frame: Up to approximately 24 months.]
Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. [Time frame: Up to approximately 24 months.]

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.
With adequate organ functions.
Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of SHR-A2102，Female participants' HCG must be negative within 72 hours prior to enrollment and must be non-lactating.

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.
Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
Had active pulmonary tuberculosis within 1 year prior to enrolment.
Known to be allergic to any of the components of SHR-A2102.
Were not fit to participate in this study by investigator's judgment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT06654440 · SHR-A2102-208