Ovarian CancerPhase 1/2NCT06990516
SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer
A Phase 1/2 study testing SHR-A1811, Carboplatin and Oxaliplatin in people with Ovarian Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
This study is a multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- SHR-A1811, Carboplatin and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2035
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily joins this study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow - up visits.
- Female, aged 18 - 75 years old (inclusive of 18 and 75 years, calculated from the date of signing the informed consent form).
- Pathologically diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (excluding mucinous carcinoma) through tissue or cytology.
- Has previously received 1 - 3 lines of platinum - containing regimens, and the disease has progressed or recurred (platinum - sensitive recurrence) ≥6 months (183 days) after the end of the last platinum - containing treatment. There must be evidence showing disease progression or recurrence (such as cytology reports of newly - developed ascites or pleural effusion) during or after the last platinum - containing treatment. Solely an elevated CA - 125 level cannot be regarded as evidence of disease progression or recurrence. The combined neoadjuvant and/or adjuvant treatment is counted as one line of treatment. Maintenance treatment is not counted separately. Treatment regimens switched due to reasons other than disease progression (such as toxicity intolerance) are considered part of the same line of treatment and are not counted separately.
- Has documented mutations in breast cancer susceptibility genes (BRCA 1/2) (germline or somatic) or is homologous recombination deficiency (HRD) positive, and has previously received poly (ADP - ribose) polymerase (PARP) inhibitor treatment.
- Is able to provide sufficient fresh or archived tumor tissue specimens for the sponsor - designated third - party central laboratory to test the HER2 expression level. The test results do not affect enrollment.
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- Has at least one measurable lesion that meets the RECIST v1.1 criteria (according to the RECIST v1.1 requirements, the long diameter of the measurable lesion on spiral CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm). Lesions that have undergone local treatment can be selected as target lesions if there is clear evidence that they have significantly progressed compared with the post - treatment state.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 - 1.
- Expected survival time ≥12 weeks.
- The functions of important organs meet the following requirements (no blood components or cytokine correction treatments have been used within 14 days before the examination):
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- Platelet count (PLT) ≥100×10⁹/L;
- Hemoglobin (Hb) ≥90 g/L;
- Serum albumin (ALB) ≥30 g/L;
- Total bilirubin ≤1.5× the upper limit of normal (ULN);
- Activated partial thromboplastin time (APTT) ≤1.5×ULN;
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastases, ALT and/or AST ≤5×ULN);
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (Clcr) ≥50 mL/min (calculated according to the Cockcroft - Gault formula);
- QTc ≤470 msec;
- Left ventricular ejection fraction (LVEF) ≥50%, and the cardiac function test results should be completed within 28 days before the first administration of the drug;
- Urine protein <2+. If urine protein ≥2+, the 24 - hour urine protein quantification must show that the protein is <1 g.
- Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first administration of the drug, and must not be breastfeeding. Female subjects of childbearing potential must agree to comply with contraceptive requirements from the date of signing the informed consent form until 7 months after the last administration of the investigational drug.
Who cannot join
- Subjects with untreated or active central nervous system (CNS) tumor metastases. Subjects with a history of leptomeningeal metastasis or current leptomeningeal metastasis. Subjects whose CNS tumor metastases have undergone adequate local treatment (surgery or radiotherapy), do not require hormone therapy, have neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment), and have been stable for ≥4 weeks can be enrolled.
- Subjects with a history of or currently having other malignancies, except for cured basal cell carcinoma of the skin, cervical intraepithelial neoplasia, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years before randomization with evidence proving no recurrence or metastasis.
- Subjects with symptomatic, poorly controlled, or moderate - to - severe pleural effusion, pericardial effusion, or ascites; subjects who have undergone effusion drainage (except diagnostic thoracentesis) can be enrolled if they have been stable for at least 2 weeks after drainage (local treatment within the serous cavity according to routine diagnosis and treatment is allowed before signing the informed consent form).
- Subjects with a history of interstitial pneumonia/interstitial lung disease or non - infectious pneumonia (such as radiation pneumonitis, etc.) that required steroid treatment; subjects with current or suspected interstitial pneumonia/interstitial lung disease, non - infectious pneumonia, or other active pneumonias; subjects who had severe asthma, severe chronic obstructive pulmonary disease (COPD), or restrictive lung disease and other lung damages within 6 months before the first administration of the drug.
- Subjects with active pulmonary tuberculosis; subjects who have undergone regular and adequate treatment before the first administration of the drug and have stopped anti - tuberculosis treatment for ≥3 months can be enrolled.
- Subjects with hypertension that cannot be well - controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, based on the average value of blood pressure readings obtained from at least 2 measurements, and the above parameters can be achieved through antihypertensive treatment), and subjects who have had hypertensive crisis or hypertensive encephalopathy in the past.
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- Subjects with uncontrolled or severe cardiovascular diseases, such as unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] class II - IV), myocardial infarction within 6 months before the first administration of the drug, or unstable angina or unstable arrhythmia within 1 month before the first administration of the drug.
- Subjects who have had arterial or venous thrombotic events within 6 months before the first administration of the drug, including but not limited to cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism; subjects with intramuscular vein thrombosis or catheter - related thrombosis of the infusion port before the first administration of the drug can be included if the investigator judges there is no risk.
- Subjects who have had NCI - CTCAE v5.0 - graded ≥Grade 2 bleeding events within 1 month before the first administration of the drug, including but not limited to hemoptysis (a single episode of hemoptysis volume ≥2 mL), vaginal bleeding, gastrointestinal bleeding; or subjects with radiation enteritis accompanied by bleeding symptoms during the screening period; subjects with positive fecal occult blood retest at baseline and judged by the investigator to have a bleeding risk cannot be enrolled.
- Note: Transient bleeding caused by iatrogenic operations is excluded.
- Subjects with known hereditary or acquired bleeding (such as coagulation disorders, hemophilia) or thrombotic tendency; subjects who have used anti - platelet drugs such as aspirin (>325 mg/d), clopidogrel, ticagrelor within 14 days before the first administration of the drug; subjects who have used anticoagulant therapy for therapeutic purposes within 2 weeks before the first administration of the drug [low - dose aspirin and low - molecular - weight heparin (such as enoxaparin sodium ≤40 mg/d) for preventive use are allowed].
- Subjects who have had gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess within 3 months before the first administration of the drug or are expected to have them in the near future; subjects who have undergone artificial fistulization or ureteral stent placement and are considered stable by the investigator after evaluation can be enrolled.
- Subjects with gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 6 months before the first administration of the drug, but subjects who have undergone surgical treatment and the obstruction has been completely relieved can be screened; subjects who have previously undergone intestinal stent implantation and the intestinal stent has not been removed until the screening period.
- Subjects who have had severe infections within 1 month before the first administration of the drug, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc.; subjects with any active infections requiring intravenous systemic treatment, or subjects who have unexplained fever >38.5°C during the screening period or before the first administration of the drug.
- Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; subjects with active hepatitis (for hepatitis B: HBsAg positive and HBV DNA detection value ≥500 IU/mL (if the research center only has copy/mL as the detection unit, subjects with ≥2500 copy/mL are not eligible), or active hepatitis C (defined as positive HCV - Ab test result during the screening period and positive HCV - RNA)).
- Subjects who underwent surgery (except diagnostic surgery), radical radiotherapy, chemotherapy, large - molecule targeted therapy, or anti - tumor immunotherapy, and the time from the completion of treatment (last medication) to the first administration of the drug is less than 4 weeks; subjects who used small - molecule targeted drugs (including other investigational oral targeted drugs) and the time from the last medication to the first administration of the drug is less than 5 half - lives or 4 weeks (whichever is shorter); subjects who underwent palliative radiotherapy or local treatment, and the time from the completion of treatment to the first administration of the drug is less than 2 weeks.
- Subjects who have previously received anti - HER2 treatment (such as HER2 ADC), or antibody - drug conjugates containing topoisomerase I inhibitors, or topoisomerase I inhibitor treatment (such as irinotecan, topotecan).
- Subjects who may receive other systemic anti - tumor treatments during the study or plan to undergo secondary cytoreductive surgery.
- According to the NCI - CTCAE v5.0 grading system, subjects whose toxicity caused by previous anti - tumor treatment has not recovered to ≤Grade 1 (except for decreased lymphocyte count, alopecia, fatigue, and laboratory indicators mentioned in the inclusion criteria; some tolerable chronic Grade 2 toxicities can be excluded after consultation between the investigator and the sponsor).
- Subjects who are known to be allergic to any component of the SHR - A1811 product (antibody - conjugated toxin, antibody, toxin SHR169265) or to any platinum - containing drug.
- In the opinion of the investigator, subjects with other factors that may affect the study results or lead to the premature termination of this study, such as alcoholism, drug abuse, drug addiction, criminal detention, etc., as well as other serious diseases (including mental illnesses) requiring concomitant treatment, severe laboratory abnormalities, and other any conditions that may increase the risk of participating in the study, interfere with the study results, or make the subject unsuitable for this study.
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
Tongji Hospital
Wuhan, Hubei, 430030
Qinglei Gao, +86-27-83662681, qingleigao@hotmail.com
About this study
Official title: An Open-label, Multi-center Phase Ib/II Clinical Study of the Combination Regimen of SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer
This study is a multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.
- Conditions
- Ovarian Cancer
- Being tested
- SHR-A1811, Carboplatin, Oxaliplatin, Bevacizumab
- 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
Dose: 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg, administered intravenously (IV) every 3 weeks (Q3W).
Infusion Duration:
First infusion: 90 ± 10 minutes. Subsequent infusions: May be shortened to approximately 30 minutes (minimum 20 minutes, maximum 60 minutes, including flush phase) if no infusion-related reactions occur after the first dose.
CarboplatinDrug
Dose: Area Under the Curve (AUC) 5 mg/mL/min, administered IV Q3W.
Infusion Duration:
Should be completed within 30-60 minutes (including flush phase).
Treatment Schedule:
Up to 6 treatment cycles, with each cycle lasting 3 weeks.
OxaliplatinDrug
Dose: 85 mg/m², administered IV Q3W.
Infusion Duration:
Should be infused over >120 minutes (including flush phase).
Treatment Schedule:
Up to 6 treatment cycles, with each cycle lasting 3 weeks.
BevacizumabDrug
Dose: 15 mg/kg, administered IV Q3W.
Infusion Duration:
First dose: 90 minutes. Second dose: If the first infusion is well-tolerated, may be shortened to 60 minutes.
Subsequent doses: If the 60-minute infusion is well-tolerated, all following infusions may be administered over 30 minutes (including flush phase).
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | SHR-A1811: Administered at 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg intravenously every 3 weeks (Q3W). Carboplatin: Administered at an area under the concentration-time curve (AUC) of 5 mg/mL/min intravenously every 3 weeks (Q3W). Oxaliplatin: Administered at 85 mg/m² intravenously every 3 weeks (Q3W). Bevacizumab: Administered at 15 mg/kg intravenously every 3 weeks (Q3W).
Treatment duration:
Platinum - based drugs (carboplatin or oxaliplatin) will be administered for a maximum of 6 cycles or until the occurrence of any event meeting the protocol - defined criteria for treatment discontinuation, whichever occurs first.
SHR-A1811 and bevacizumab will be continued until the occurrence of any event meeting the protocol - defined criteria for treatment discontinuation. Receives: Drug: SHR-A1811; Drug: Carboplatin; Drug: Oxaliplatin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR):
Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). For responses categorized as CR or PR, confirmation is required through a subsequent evaluation performed no less than 4 weeks (≥28 days) after the initial assessment.
Measured: 5 Years after treatment.
Secondary outcomes (6)
Duration of Response (DoR)
Defined as the time from the first date a subject is assessed as having a confirmed Complete Response (CR) or Partial Response (PR) to the first date of either Progressive Disease (PD) or death due to any cause, whichever occurs first.
Measured: 5 Years after treatment.
Disease Control Rate (DCR)
Defined as the proportion of subjects with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: 5 Years after treatment.
Response Rate (RR)
Defined as the proportion of subjects with an overall response assessed as either a response according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or a response according to the Gynecologic Cancer InterGroup (GCIG) CA - 125 criteria.
Measured: 5 Years after treatment.
CA - 125 Response Rate (CA - 125 RR)
Defined as the proportion of subjects with a response evaluated according to the Gynecologic Cancer InterGroup (GCIG) CA - 125 criteria.
Measured: 5 Years after treatment.
Progression Free Survival
Progression - Free Survival (PFS) as assessed by the Independent Radiological Review Committee (IRC) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). It is defined as the time from the randomization date of the subject to the first date of documented radiological tumor progression or the date of death due to any cause, whichever occurs first.
Measured: 5 Years after treatment.
Overall Survival (OS)
Defined as the time from the randomization date to death due to any cause in subjects.
Measured: 5 Years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2035 (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 Tongji HospitalThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
- Investigators
- Qinglei Gao, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990516
- Sponsor's protocol ID
- 2025-TJ-OVA1811S
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact Prof. Gao for primary data.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase Ib/II Clinical Study of the Combination Regimen of SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06990516
- Acronym / sponsor ID
- 2025-TJ-OVA1811S
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2035 (estimated)
- First posted
- 25 May 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 multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.
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 | Experimental | Drug: SHR-A1811, Drug: Carboplatin, Drug: Oxaliplatin, Drug: BevacizumabSHR-A1811: Administered at 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg intravenously every 3 weeks (Q3W). Carboplatin: Administered at an area under the concentration-time curve (AUC) of 5 mg/mL/min intravenously every 3 weeks (Q3W). Oxaliplatin: Administered at 85 mg/m² intravenously every 3 weeks (Q3W). Bevacizumab: Administered at 15 mg/kg intravenously every 3 weeks (Q3W). Treatment duration: Platinum - based drugs (carboplatin or oxaliplatin) will be administered for a maximum of 6 cycles or until the occurrence of any event meeting the protocol - defined criteria for treatment discontinuation, whichever occurs first. SHR-A1811 and bevacizumab will be continued until the occurrence of any event meeting the protocol - defined criteria for treatment discontinuation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Voluntarily joins this study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow - up visits.
- Female, aged 18 - 75 years old (inclusive of 18 and 75 years, calculated from the date of signing the informed consent form).
- Pathologically diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (excluding mucinous carcinoma) through tissue or cytology.
- Has previously received 1 - 3 lines of platinum - containing regimens, and the disease has progressed or recurred (platinum - sensitive recurrence) ≥6 months (183 days) after the end of the last platinum - containing treatment. There must be evidence showing disease progression or recurrence (such as cytology reports of newly - developed ascites or pleural effusion) during or after the last platinum - containing treatment. Solely an elevated CA - 125 level cannot be regarded as evidence of disease progression or recurrence. The combined neoadjuvant and/or adjuvant treatment is counted as one line of treatment. Maintenance treatment is not counted separately. Treatment regimens switched due to reasons other than disease progression (such as toxicity intolerance) are considered part of the same line of treatment and are not counted separately.
- Has documented mutations in breast cancer susceptibility genes (BRCA 1/2) (germline or somatic) or is homologous recombination deficiency (HRD) positive, and has previously received poly (ADP - ribose) polymerase (PARP) inhibitor treatment.
Key exclusion criteria (21 listed)
- Subjects with untreated or active central nervous system (CNS) tumor metastases. Subjects with a history of leptomeningeal metastasis or current leptomeningeal metastasis. Subjects whose CNS tumor metastases have undergone adequate local treatment (surgery or radiotherapy), do not require hormone therapy, have neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment), and have been stable for ≥4 weeks can be enrolled.
- Subjects with a history of or currently having other malignancies, except for cured basal cell carcinoma of the skin, cervical intraepithelial neoplasia, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years before randomization with evidence proving no recurrence or metastasis.
- Subjects with symptomatic, poorly controlled, or moderate - to - severe pleural effusion, pericardial effusion, or ascites; subjects who have undergone effusion drainage (except diagnostic thoracentesis) can be enrolled if they have been stable for at least 2 weeks after drainage (local treatment within the serous cavity according to routine diagnosis and treatment is allowed before signing the informed consent form).
- Subjects with a history of interstitial pneumonia/interstitial lung disease or non - infectious pneumonia (such as radiation pneumonitis, etc.) that required steroid treatment; subjects with current or suspected interstitial pneumonia/interstitial lung disease, non - infectious pneumonia, or other active pneumonias; subjects who had severe asthma, severe chronic obstructive pulmonary disease (COPD), or restrictive lung disease and other lung damages within 6 months before the first administration of the drug.
- Subjects with active pulmonary tuberculosis; subjects who have undergone regular and adequate treatment before the first administration of the drug and have stopped anti - tuberculosis treatment for ≥3 months can be enrolled.
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-A1811Dose: 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg, administered intravenously (IV) every 3 weeks (Q3W). Infusion Duration: First infusion: 90 ± 10 minutes. Subsequent infusions: May be shortened to approximately 30 minutes (minimum 20 minutes, maximum 60 minutes, including flush phase) if no infusion-related reactions occur after the first dose. | Drug | SHR-A1811 |
| CarboplatinDose: Area Under the Curve (AUC) 5 mg/mL/min, administered IV Q3W. Infusion Duration: Should be completed within 30-60 minutes (including flush phase). Treatment Schedule: Up to 6 treatment cycles, with each cycle lasting 3 weeks. | Drug | SHR-A1811 |
| OxaliplatinDose: 85 mg/m², administered IV Q3W. Infusion Duration: Should be infused over >120 minutes (including flush phase). Treatment Schedule: Up to 6 treatment cycles, with each cycle lasting 3 weeks. | Drug | SHR-A1811 |
| BevacizumabDose: 15 mg/kg, administered IV Q3W. Infusion Duration: First dose: 90 minutes. Second dose: If the first infusion is well-tolerated, may be shortened to 60 minutes. Subsequent doses: If the 60-minute infusion is well-tolerated, all following infusions may be administered over 30 minutes (including flush phase). | Drug | SHR-A1811 |
Primary outcome
Objective Response Rate (ORR):
Time frame: 5 Years after treatment.
Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). For responses categorized as CR or PR, confirmation is required through a subsequent evaluation performed no less than 4 weeks (≥28 days) after the initial assessment.
6 secondary outcomes
Duration of Response (DoR)
Time frame: 5 Years after treatment.
Disease Control Rate (DCR)
Time frame: 5 Years after treatment.
Response Rate (RR)
Time frame: 5 Years after treatment.
CA - 125 Response Rate (CA - 125 RR)
Time frame: 5 Years after treatment.
Progression Free Survival
Time frame: 5 Years after treatment.
Overall Survival (OS)
Time frame: 5 Years after treatment.
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 25 May 2025.
- Individual participant dataSharing planned: No. Contact Prof. Gao for primary data.
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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.
Qinglei Gao principal investigator
Tongji Hospital
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 Oxaliplatin in people with Ovarian Cancer, run by Tongji Hospital 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 23 inclusion and 21 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: opening soon, as of the sponsor's last update on 25 May 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 Qinglei Gao (+86-27-83662681, qingleigao@hotmail.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: 5 Years after treatment.). 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 25 May 2025.