SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer (NCT06990516) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer
China90 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.