SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer

NCT06990516 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025-TJ-OVA1811S
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  5 Years after treatment.

Secondary Outcomes (6)

• Duration of Response (DoR)

  5 Years after treatment.

• Disease Control Rate (DCR)

  5 Years after treatment.

• Response Rate (RR)

  5 Years after treatment.

• CA - 125 Response Rate (CA - 125 RR)

  5 Years after treatment.

• Progression Free Survival

  5 Years after treatment.

Study Arms (1)

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.

Drug: SHR-A1811; Drug: Carboplatin; Drug: Oxaliplatin; Drug: Bevacizumab

Interventions

SHR-A1811 DRUG

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.

SHR-A1811

Carboplatin DRUG

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.

SHR-A1811

Oxaliplatin DRUG

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.

SHR-A1811

Bevacizumab DRUG

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).

SHR-A1811

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Ovarian cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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);

You may not qualify if:

• 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.
• 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)).

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Qinglei Gao

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinglei Gao

CONTACT

+86-27-83662681; qingleigao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2035
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)