Clinical trial NCT06654440: A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy
Official title: An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Gynecological Malignancy
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
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.
Secondary outcomes:
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.
measure: Disease control rate (DCR)
timeFrame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
measure: Time to response (TTR)
timeFrame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
measure: Progression free survival (PFS)
timeFrame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
measure: Overall survival (OS)
timeFrame: follow up once every 60 days. Up to approximately 36 months.
measure: 12 month survival rate
timeFrame: follow up once every 60 days. Up to approximately 24 months.
measure: Adverse Events (AEs)
timeFrame: Up to approximately 24 months.
measure: PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.
timeFrame: Up to approximately 24 months.
measure: PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.
timeFrame: Up to approximately 24 months.
measure: ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
timeFrame: Up to approximately 24 months.
measure: Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
timeFrame: Up to approximately 24 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: