Ovarian CancerPhase 1/2NCT06840002
A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
A Phase 1/2 study testing SHR-A1811, Carboplatin and Bevacizumab in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- SHR-A1811, Carboplatin and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2025to Dec 2026
- 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
- Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
- Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
- At least one measurable lesion conforming to RECIST v1.1.
- ECOG PS score: 0-1.
- Expected survival ≥ 12 weeks.
- Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.
Who cannot join
- With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
- Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
- Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
- With hypertension and cannot be well controlled by antihypertensive drug treatment.
- Accompanied by poorly controlled or serious cardiovascular diseases.
- Subjects with serious infection within 1 month before the first medication.
- Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
- There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.
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
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Qinglei Gao, 13871127473, qingleigao@hotmail.com
Qinglei Gao
About this study
Official title: An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- SHR-A1811, Carboplatin, Bevacizumab, Oxaliplatin for Injection, Paclitaxel injection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811.
CarboplatinDrug
Carboplatin.
BevacizumabDrug
Bevacizumab.
Oxaliplatin for InjectionDrug
Oxaliplatin for injection.
Paclitaxel injectionDrug
Paclitaxel injection.
Doxorubicin hydrochloride liposome injectionDrug
Doxorubicin hydrochloride liposome injection.
Adebrelimab InjectionDrug
Adebrelimab injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Carboplatin; Drug: Bevacizumab; Drug: Oxaliplatin for Injection; Drug: Paclitaxel injection; Drug: Doxorubicin hydrochloride liposome injection; Drug: Adebrelimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT)
Measured: Up to 21 days.
Recommended phase II dose (RP2D)
Measured: Up to 21 days.
Objective response rate (ORR)
Measured: Every 9 weeks lasting about one year.
Secondary outcomes (7)
Duration of response (DoR)
Measured: Every 9 weeks lasting about one year.
Disease control rate (DCR)
Measured: Every 9 weeks lasting about one year.
Progression free survival (PFS)
Measured: Every 9 weeks lasting about one year.
Standard response rate (RR)
Measured: Every 9 weeks lasting about one year.
Overall survival (OS)
Measured: Approximately 3 years after the last subject enrolled.
Adverse events (AEs)
Measured: From the first drug administration to within 90 days after the last dose.
Serious adverse events (SAEs)
Measured: From the first drug administration to within 90 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start18 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT06840002
- Sponsor's protocol ID
- SHR-A1811-216-OC
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2025
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06840002
- Acronym / sponsor ID
- SHR-A1811-216-OC
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Feb 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.
The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-A1811, Drug: Carboplatin, Drug: Bevacizumab, Drug: Oxaliplatin for Injection, Drug: Paclitaxel injection, Drug: Doxorubicin hydrochloride liposome injection, Drug: Adebrelimab 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 form, have good compliance, and can cooperate with the follow-up.
- Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
- At least one measurable lesion conforming to RECIST v1.1.
- ECOG PS score: 0-1.
- Expected survival ≥ 12 weeks.
Key exclusion criteria (8 listed)
- With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
- Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
- Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
- With hypertension and cannot be well controlled by antihypertensive drug treatment.
- Accompanied by poorly controlled or serious cardiovascular diseases.
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. | Drug | Treatment group |
| CarboplatinCarboplatin. | Drug | Treatment group |
| BevacizumabBevacizumab. | Drug | Treatment group |
| Oxaliplatin for InjectionOxaliplatin for injection. | Drug | Treatment group |
| Paclitaxel injectionPaclitaxel injection. | Drug | Treatment group |
| Doxorubicin hydrochloride liposome injectionDoxorubicin hydrochloride liposome injection. | Drug | Treatment group |
| Adebrelimab InjectionAdebrelimab injection. | Drug | Treatment group |
Primary outcome
Dose limited toxicity (DLT)
Time frame: Up to 21 days.
Recommended phase II dose (RP2D)
Time frame: Up to 21 days.
Objective response rate (ORR)
Time frame: Every 9 weeks lasting about one year.
7 secondary outcomes
Duration of response (DoR)
Time frame: Every 9 weeks lasting about one year.
Disease control rate (DCR)
Time frame: Every 9 weeks lasting about one year.
Progression free survival (PFS)
Time frame: Every 9 weeks lasting about one year.
Standard response rate (RR)
Time frame: Every 9 weeks lasting about one year.
Overall survival (OS)
Time frame: Approximately 3 years after the last subject enrolled.
Adverse events (AEs)
Time frame: From the first drug administration to within 90 days after the last dose.
Serious adverse events (SAEs)
Time frame: From the first drug administration to within 90 days after the last dose.
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 11 Sep 2026.
- 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, Carboplatin and Bevacizumab in people with Ovarian 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 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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 Shuni Wang (+86-0518-81220121, shuni.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) (time frame: Up to 21 days.). 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 11 Sep 2026.