The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate (ORR) — Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months. Assessed by Investigator according to RECIST 1.1 criteria.
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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