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New treatment option for Advanced Gynecological Malignancy
Official title A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy
ClinicalTrials.gov ID: NCT06654440
What this study is testing
What is SHR-A2102 for injection?
SHR-A2102 for injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced gynecological malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.