Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer

Exclusion Criteria

• •• Central nervous system (CNS) metastasis or cancerous meningitis (Note: Subjects with treated CNS metastases may participate in this trial if the subject is neurologically stable ≥3 months).
• •* Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast.
• •* Received any of the following treatments within a specific time frame prior to enrollment:
• •1. Have received surgery of Grade II or above within 4 weeks (Whether or not related to tumor), except minimally invasive surgery under gastrointestinal endoscopy;
• •2. Have received radiotherapy within 2 weeks (the investigator can judge the appropriate time of enrollment according to the patient's toxicity recovery after radiotherapy);
• •3. Within 4 weeks or participating in other therapeutic/interventional clinical studies;
• •4. Have received local anti-tumor treatment within 4 weeks;
• •* Allergic to the test drug or its active ingredients and excipients.
• •* Has had severe allergic reaction after receiving smallpox vaccine in the past.
• •* Has a history of severe skin diseases requiring systemic treatment within 2 years, such as eczema, atopic dermatitis, burns, seborrheic dermatitis, psoriasis, severe acne, etc.
• •* Has had an allogenic tissue/solid organ transplant.
• •* Active infection or fever of unknown cause (\>38.5 ℃).
• •* Active pulmonary tuberculosis (TB) who are receiving anti tuberculosis treatment or who have received anti tuberculosis treatment within 1 year before screening;
• •* Positive anti-HIV (+) or anti-HCV (+) or syphilis specific antibody (TPHA) or active hepatitis B.
• •* Has a history of serious cardiovascular or cerebrovascular diseases, including but not limited to:
• •1. New York Heart Association (NYHA) congestive heart failure of grade III or above;
• •2. Serious arrhythmia requiring drug treatment;
• •3. Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, and stenting occurred within 6 months;
• •4. Left ventricular ejection fraction (EF)\<60%;
• •5. QTcF interval ≥ 460 ms, or there are risk factors of torsade de pointes ventricular tachycardia, such as hypokalemia, family history of long QT syndrome or family history of arrhythmia (such as preexcitation syndrome);
• •6. Presence of uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic BP\>100 mmHg).
• •* Active autoimmune diseases such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autohemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis), but the following conditions are allowed to enter the screening: type I diabetes, hypothyroidism that can be controlled only through alternative treatment, skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia).
• •* Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \> once every 14 days.
• •* Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
• •* Active gastrointestinal bleeding.
• •* Accompanied by unstable mental illness, alcohol abuse, drug abuse or drug abuse.
• •* Other conditions that investigator considers unsuitable for this study.