Recurrent or Metastatic Cervical CancerPhase 1/2NCT06859775
SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
A Phase 1/2 study testing SHR-A1811, Adebelimab injection and Bevacizumab injection in people with Recurrent or Metastatic Cervical Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of… 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, Adebelimab injection and Bevacizumab 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
- 25 Apr 2025to Jan 2027
- Phase
- Phase 1/2
- 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
- Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
- Female, aged 18-75 years old.
- Expected survival ≥ 12 weeks.
- Normal function of vital organs.
- Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
- Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.
Who cannot join
- Previous or concomitant other malignancies.
- Severe bone damage caused by bone metastasis from tumours.
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
- Those with active tuberculosis.
- Concomitant poorly controlled or severe cardiovascular disease.
- Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
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- Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
- Subjects who have had a serious infection within 1 month before the first dose.
- Subjects who have a history of immunodeficiency.
- As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.
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
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Yang Xiang, +86-010-69156086, XiangY@pumch.cn
Yang Xiang
About this study
Official title: Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Being tested
- SHR-A1811, Adebelimab injection, Bevacizumab injection, SHR-8068, Cisplatin 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-A1811Drug
SHR-A1811 injection.
Adebelimab injectionDrug
Adebelimab injection.
Bevacizumab injectionDrug
Bevacizumab injection.
SHR-8068Drug
SHR-8068 injection.
Cisplatin injectionDrug
Cisplatin injection.
Carboplatin injectionDrug
Carboplatin injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment cohort 1 | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection |
| Treatment cohort 2 | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection; Drug: SHR-8068 |
| Treatment cohort 3 | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection; Drug: SHR-8068; Drug: Cisplatin injection; Drug: Carboplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade≥3 drug-related adverse events (TRAEs).
Measured: Up to 3 years.
Grade≥3 drug-related serious adverse events (TRAEs).
Measured: Up to 3 years.
Objective response rate (ORR).
Measured: Up to 3 years.
Secondary outcomes (4)
Duration of response (DOR).
Measured: Up to 3 years.
Disease control rate (DCR).
Measured: Up to 3 years.
Progression-free survival (PFS).
Measured: Up to 3 years.
Overall survival (OS).
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start25 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (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 Suzhou Suncadia Biopharmaceuticals 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859775
- Sponsor's protocol ID
- SHR-A1811-216-CC
- Status last verified
- Jun 2025
- First submitted
- 27 Feb 2025
- Last updated
- 6 Jun 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT06859775
- Acronym / sponsor ID
- SHR-A1811-216-CC
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Mar 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 multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment cohort 1 | Experimental | Drug: SHR-A1811, Drug: Adebelimab injection, Drug: Bevacizumab injection |
| Treatment cohort 2 | Experimental | Drug: SHR-A1811, Drug: Adebelimab injection, Drug: Bevacizumab injection, Drug: SHR-8068 |
| Treatment cohort 3 | Experimental | Drug: SHR-A1811, Drug: Adebelimab injection, Drug: Bevacizumab injection, Drug: SHR-8068, Drug: Cisplatin injection, Drug: Carboplatin 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)
- Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
- Female, aged 18-75 years old.
- Expected survival ≥ 12 weeks.
- Normal function of vital organs.
- Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
Key exclusion criteria (10 listed)
- Previous or concomitant other malignancies.
- Severe bone damage caused by bone metastasis from tumours.
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
- Those with active tuberculosis.
- Concomitant poorly controlled or severe cardiovascular disease.
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-A1811SHR-A1811 injection. | Drug | Treatment cohort 1, Treatment cohort 2, Treatment cohort 3 |
| Adebelimab injectionAdebelimab injection. | Drug | Treatment cohort 1, Treatment cohort 2, Treatment cohort 3 |
| Bevacizumab injectionBevacizumab injection. | Drug | Treatment cohort 1, Treatment cohort 2, Treatment cohort 3 |
| SHR-8068SHR-8068 injection. | Drug | Treatment cohort 2, Treatment cohort 3 |
| Cisplatin injectionCisplatin injection. | Drug | Treatment cohort 3 |
| Carboplatin injectionCarboplatin injection. | Drug | Treatment cohort 3 |
Primary outcome
Grade≥3 drug-related adverse events (TRAEs).
Time frame: Up to 3 years.
Grade≥3 drug-related serious adverse events (TRAEs).
Time frame: Up to 3 years.
Objective response rate (ORR).
Time frame: Up to 3 years.
4 secondary outcomes
Duration of response (DOR).
Time frame: Up to 3 years.
Disease control rate (DCR).
Time frame: Up to 3 years.
Progression-free survival (PFS).
Time frame: Up to 3 years.
Overall survival (OS).
Time frame: Up to 3 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 6 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1811, Adebelimab injection and Bevacizumab injection in people with Recurrent or Metastatic Cervical Cancer, run by Suzhou Suncadia Biopharmaceuticals 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 10 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 6 Jun 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Grade≥3 drug-related adverse events (TRAEs). (time frame: Up to 3 years.). The study lists 3 primary outcomes in all. 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 6 Jun 2025.