Advanced Gynecological Malignancy
Conditions
Brief summary
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
Interventions
SHR-A2102 for injection
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) | 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. |
| Disease control rate (DCR) | 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. |
| Time to response (TTR) | 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. |
| Progression free survival (PFS) | 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. |
| Overall survival (OS) | follow up once every 60 days. Up to approximately 36 months. | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. |
| 12 month survival rate | follow up once every 60 days. Up to approximately 24 months. | Survival rate within one year. |
| Adverse Events (AEs) | Up to approximately 24 months. | Include incidence,grade(judged according to NCI-CTCAE V5.0 standards). |
| PK traits of SHR-A2102: Plasma concentrations of SHR-A2102. | Up to approximately 24 months. | — |
| PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites. | Up to approximately 24 months. | — |
| ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. | Up to approximately 24 months. | — |
| Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. | Up to approximately 24 months. | — |
Countries
China
Contacts
Primary ContactZhiFei Lin, M.M
Outcome results
None listed