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Recruiting Phase 2 NCT06654440

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

Trial Parameters

Condition Advanced Gynecological Malignancy
Sponsor Shanghai Hengrui Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2024-11-15
Completion 2025-08-31
Interventions
SHR-A2102 for injection

Brief Summary

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

Eligibility Criteria

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 et

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