Advanced Gynecological MalignancyPhase 2NCT06654440
A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy
A Phase 2 study testing SHR-A2102 for injection in people with Advanced Gynecological Malignancy, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Gynecological Malignancy
- What is being tested?
- SHR-A2102 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 31 Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the study voluntarily, sign the informed consent form.
- Recurrent or metastatic gynecological malignancies that had failed standard treatments.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0~ 1.
- With adequate organ functions.
- 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.
Who cannot join
- With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.
- 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.
- Had previously received antibody drug conjugates containing topoisomerase I inhibitors.
- 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.
- Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
- Had active pulmonary tuberculosis within 1 year prior to enrolment.
- Known to be allergic to any of the components of SHR-A2102.
- Were not fit to participate in this study by investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu
Jihong Liu
About this study
Official title: An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
- Conditions
- Advanced Gynecological Malignancy
- Being tested
- SHR-A2102 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102 for injectionDrug
SHR-A2102 for injection
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Not described Receives: Drug: SHR-A2102 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Assessed by Investigator according to RECIST 1.1 criteria.
Measured: 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 (11)
Duration of response (DoR)
Assessed by Investigator according to RECIST 1.1 criteria.
Measured: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Disease control rate (DCR)
Assessed by Investigator according to RECIST 1.1 criteria.
Measured: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Time to response (TTR)
Assessed by Investigator according to RECIST 1.1 criteria.
Measured: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Progression free survival (PFS)
Assessed by Investigator according to RECIST 1.1 criteria.
Measured: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Measured: follow up once every 60 days. Up to approximately 36 months.
12 month survival rate
Survival rate within one year.
Measured: follow up once every 60 days. Up to approximately 24 months.
Adverse Events (AEs)
Include incidence,grade(judged according to NCI-CTCAE V5.0 standards).
Measured: Up to approximately 24 months.
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.
Measured: Up to approximately 24 months.
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.
Measured: Up to approximately 24 months.
ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
Measured: Up to approximately 24 months.
Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start15 Nov 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gynecological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654440
- Sponsor's protocol ID
- SHR-A2102-208
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided