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

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

Recruiting
18-75 years
Female
Phase 2

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Overview

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

Eligibility

Inclusion Criteria:

  1. Participate in the study voluntarily, sign the informed consent form.
  2. Recurrent or metastatic gynecological malignancies that had failed standard treatments.
  3. At least one measurable lesion (RECIST version 1.1).
  4. ECOG 0~ 1.
  5. With adequate organ functions.
  6. 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.

Exclusion Criteria

  1. With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.
  2. 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.
  3. Had previously received antibody drug conjugates containing topoisomerase I inhibitors.
  4. 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.
  5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
  6. Had active pulmonary tuberculosis within 1 year prior to enrolment.
  7. Known to be allergic to any of the components of SHR-A2102.
  8. Were not fit to participate in this study by investigator's judgment.

Study details
    Advanced Gynecological Malignancy

NCT06654440

Shanghai Hengrui Pharmaceutical Co., Ltd.

4 September 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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