Clinical trial · Interventional
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
NCT05896020CI-TRIAL-00068960unknownPhase 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)
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.
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 |
|---|---|---|---|
| Gynaecological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR- A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group with SHR-A1811
- interventionNames
- Drug: SHR- A1811
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 12 months
Secondary outcomes (6)
- measure
- Progression free survival (PFS)
- timeFrame
- 12 months
- measure
- Objective response rate (ORR)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subjects voluntarily joined the study and signed the ICF. 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. 5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer. Exclusion Criteria: 1. Symptomatic, untreated or active central nervous system metastases. 2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc.. 3. Have uncontrolled or severe cardiovascular disease. 4. With any active autoimmune disease or history of autoimmune disease. 5. Patients with active hepatitis B or hepatitis C. 6. Severe infections within 28 days prior to initiation of study treatment. 7. Active tuberculosis within one year prior to initiation of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.