Gynaecological MalignanciesPhase 2NCT05896020
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
A Phase 2 study testing SHR- A1811 in people with Gynaecological Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Gynaecological Malignancies
- What is being tested?
- SHR- A1811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 15 Jun 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
- The subjects voluntarily joined the study and signed the ICF.
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.
Who cannot join
- Symptomatic, untreated or active central nervous system metastases.
- Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..
- Have uncontrolled or severe cardiovascular disease.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections within 28 days prior to initiation of study treatment.
- Active tuberculosis within one year prior to initiation of study treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Beihua Kong, Doctor, +86-18653199168, kongbeihua@sdu.edu.cn
About this study
Official title: Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.
- Conditions
- Gynaecological Malignancies
- Being tested
- SHR- A1811
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR- A1811Drug
Subjects with gynaecological malignancies
| Study group | Role | What they receive |
|---|---|---|
| Treatment group with SHR-A1811 | Experimental | Not described Receives: Drug: SHR- A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 12 months
Secondary outcomes (6)
Progression free survival (PFS)
Measured: 12 months
Objective response rate (ORR)
Measured: 12 months
Disease control rate (DCR)
Measured: 12 months
Duration of response (DOR)
Measured: 12 months
Overall survival (OS)
Measured: 12 months
Incidence and severity of adverse events (AEs)
Measured: From Day 1 to 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start10 Jul 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological MalignanciesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Model description
- Single arm study of SHR-A1811
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896020
- Sponsor's protocol ID
- SHR-A1811-209
- Status last verified
- Aug 2023
- First submitted
- 28 May 2023
- Last updated
- 22 Aug 2023
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
- ClinicalTrials.gov ID
- NCT05896020
- Acronym / sponsor ID
- SHR-A1811-209
- Conditions
- Gynaecological Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 9 Jun 2023 (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.
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study of SHR-A1811
| Arm | Type | Receives |
|---|---|---|
| Treatment group with SHR-A1811 | Experimental | Drug: SHR- A1811 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects voluntarily joined the study and signed the ICF.
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.
Key exclusion criteria (7 listed)
- Symptomatic, untreated or active central nervous system metastases.
- Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..
- Have uncontrolled or severe cardiovascular disease.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
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- A1811Subjects with gynaecological malignancies | Drug | Treatment group with SHR-A1811 |
Primary outcome
Objective response rate (ORR)
Time frame: 12 months
6 secondary outcomes
Progression free survival (PFS)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Disease control rate (DCR)
Time frame: 12 months
Duration of response (DOR)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Incidence and severity of adverse events (AEs)
Time frame: From Day 1 to 90 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- 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- A1811 in people with Gynaecological Malignancies, run by Jiangsu HengRui Medicine 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 5 inclusion and 7 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 22 Aug 2023. 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 Bo Li, Ph.D. (+86 021-61053363, bo.li@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: 12 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 22 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.