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
- Are there results?
- None posted in the registry
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.
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.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies
- ClinicalTrials.gov ID
- NCT06654440
- Acronym / sponsor ID
- SHR-A2102-208
- Conditions
- Advanced Gynecological Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Drug: SHR-A2102 for injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A2102 for injectionSHR-A2102 for injection | Drug | Single Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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.
11 secondary outcomes
Duration of response (DoR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: follow up once every 60 days. Up to approximately 36 months.
12 month survival rate
Time frame: follow up once every 60 days. Up to approximately 24 months.
Adverse Events (AEs)
Time frame: Up to approximately 24 months.
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.
Time frame: Up to approximately 24 months.
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.
Time frame: Up to approximately 24 months.
ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
Time frame: Up to approximately 24 months.
Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
Time frame: Up to approximately 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZhiFei Lin, M.M (18702197991, zhifei.lin.zl3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.