Recurrent or Metastatic Cervical CancerPhase 2NCT07051486
A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
A Phase 2 study testing SHR-A1811 Injection in people with Recurrent or Metastatic Cervical Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent or Metastatic Cervical Cancer
- What is being tested?
- SHR-A1811 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2025to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
- Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
- Cervical cancer confirmed by tissue or cytological pathology.
- Expected survival ≥ 12 weeks.
- Normal function of important organs.
- Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months.
Who cannot join
- Subjects with known untreated or active central nervous system (CNS) tumor metastases.
- Subjects with other malignant tumors in the past or at the same time.
- Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
- Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
- Subjects with known lung damage caused by concurrent lung diseases.
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- Subjects with active pulmonary tuberculosis.
- Subjects with poorly controlled or severe cardiovascular diseases.
- Subjects with arterial/venous thrombotic events within 1 month before enrollment.
- Subjects who had a serious infection within 1 month before enrollment.
- History of immunodeficiency, including positive HIV test.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350011
Yang Sun, +86-0591-83660063, doctorsunyang@sina.com
Yang Sun
- Recruiting
Shandong University Qilu Hospital
Jinan, Shandong, 250063
Beihua Kong, +86-0531-82169114, Kongbeihua@sdu.edu.cn
Kun Song, +86-0531-82169114, Songkun2001226@sdu.edu.cn
About this study
Official title: A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment
This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Being tested
- SHR-A1811 Injection
- Medical subject headings
- Recurrence, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811 InjectionDrug
SHR-A1811 for injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 Group | Experimental | Not described Receives: Drug: SHR-A1811 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Measured: Up to 2 years.
Secondary outcomes (11)
Overall survival (OS) assessed by Independent Review Committee (IRC)
Measured: Up to 2 years.
Overall survival (OS) assessed by investigators
Measured: Up to 2 years.
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Measured: Up to 2 years.
Progression free survival (PFS) assessed by investigators
Measured: Up to 2 years.
Duration of response (DoR) assessed by Independent Review Committee (IRC)
Measured: Up to 2 years.
Duration of response (DoR) assessed by investigators
Measured: Up to 2 years.
Disease control rate (DCR) assessed by Independent Review Committee (IRC)
Measured: Up to 2 years.
Disease control rate (DCR) assessed by investigators
Measured: Up to 2 years.
Objective response rate (ORR) assessed by investigators
Measured: Up to 2 years.
Adverse events (AEs)
Measured: Up to 2 years.
Serious adverse events (SAEs)
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start11 Oct 2025
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Cervical CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07051486
- Sponsor's protocol ID
- SHR-A1811-218
- Status last verified
- Oct 2025
- First submitted
- 26 Jun 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment
- ClinicalTrials.gov ID
- NCT07051486
- Acronym / sponsor ID
- SHR-A1811-218
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Jul 2025 (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 study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 Group | Experimental | Drug: SHR-A1811 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)
- Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
- Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
- Cervical cancer confirmed by tissue or cytological pathology.
- Expected survival ≥ 12 weeks.
- Normal function of important organs.
Key exclusion criteria (11 listed)
- Subjects with known untreated or active central nervous system (CNS) tumor metastases.
- Subjects with other malignant tumors in the past or at the same time.
- Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
- Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
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-A1811 InjectionSHR-A1811 for injection. | Drug | SHR-A1811 Group |
Primary outcome
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
11 secondary outcomes
Overall survival (OS) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Overall survival (OS) assessed by investigators
Time frame: Up to 2 years.
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Progression free survival (PFS) assessed by investigators
Time frame: Up to 2 years.
Duration of response (DoR) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Duration of response (DoR) assessed by investigators
Time frame: Up to 2 years.
Disease control rate (DCR) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Disease control rate (DCR) assessed by investigators
Time frame: Up to 2 years.
Objective response rate (ORR) assessed by investigators
Time frame: Up to 2 years.
Adverse events (AEs)
Time frame: Up to 2 years.
Serious adverse events (SAEs)
Time frame: Up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- 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.
2 sites 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 Injection in people with Recurrent or Metastatic Cervical Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 11 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na An (+86-0518-82342973, na.an@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) assessed by Independent Review Committee (IRC) (time frame: Up to 2 years.). 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 17 Nov 2025.