NCT06654440 A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy
| NCT ID | NCT06654440 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
| Condition | Advanced Gynecological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-11-15 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06654440 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Advanced Gynecological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06654440 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06654440 currently recruiting?
Yes, NCT06654440 is actively recruiting participants. Contact the research team at zhifei.lin.zl3@hengrui.com for enrollment information.
Where is the NCT06654440 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06654440 clinical trial?
NCT06654440 is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. The trial plans to enroll 100 participants.