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Trial Title:
A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy
NCT ID:
NCT06654440
Condition:
Advanced Gynecological Malignancy
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A2102 for injection
Description:
SHR-A2102 for injection
Arm group label:
Single Group
Summary:
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102
for participants with advanced gynaecological cancer.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Contact:
Last name:
Jihong Liu
Investigator:
Last name:
Jihong Liu
Email:
Principal Investigator
Start date:
November 30, 2024
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654440
