Clinical trial · Interventional
A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy
An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies
NCT06654440CI-TRIAL-00083521recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gynecological Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A2102 for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group
- interventionNames
- Drug: SHR-A2102 for injection
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
- description
- Assessed by Investigator according to RECIST 1.1 criteria.
Secondary outcomes (11)
- measure
- Duration of response (DoR)
- timeFrame
- Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
- description
- Assessed by Investigator according to RECIST 1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.