Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer
Recruiting
Phase 1Interventional Study
Ovarian Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Tongji Hospital · Other
Who this trial is looking for
This trial is looking for patients with recurrent or hard-to-treat ovarian cancer. Participants will receive the experimental drug KM1 to see how well it works and if they can tolerate it.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with recurrent or refractory ovarian cancer.
I have previously received treatment that included a platinum-based chemotherapy.
I have a performance status of 0 or 1.
I expect to live at least 3 more months.
I have at least one measurable target lesion.
My kidney, liver, and bone marrow function are adequate.
I have a negative pregnancy test if I am of childbearing age.
I willingly agree to participate and will cooperate with follow-ups.
You may not be able to join if
I have central nervous system metastasis or cancerous meningitis.
I have had another active cancer in the last 3 years, except for certain curable cancers.
I had recent surgery, radiotherapy, or participated in other clinical studies.
I am allergic to the drug KM1 or its ingredients.
I have severe skin diseases needing systemic treatment.
I have an active infection or unexplained fever.
I have serious heart or blood vessel diseases.
I have active autoimmune diseases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to determine if KM1 is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer, and explore the Recommend Phase 2 Dose (RP2D) of KM1 in the treatment of patients with recurrent or refractory ovarian cancer.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically or cytopathology confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, except mucinous cancer.
* Relapsed/refractory subjects who failed to receive systemic treatment (at least one standard platinum containing regimen); Note: I…
Inclusion Criteria:
* Histologically or cytopathology confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, except mucinous cancer.
* Relapsed/refractory subjects who failed to receive systemic treatment (at least one standard platinum containing regimen); Note: If the disease relapses, there should be evidence showing imaging or clinical progress (such as cytological report of new ascites or pleural effusion). Only the increase of CA125 cannot be used as the standard of disease recurrence.
* Performance status ECOG of 0 or 1.
* Life expectancy of at least 3 months.
* Toxicities of prior therapies have not been resolved to Grade 1 or baseline (except for alopecia, pigmentation or other toxicity considered as no safety risk to the subject in the study).
* At least 1 measurable target lesion by RECIST 1.1.
* Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.
* Pregnancy test results within 14 days before the treatment were negative. Subjects of childbearing age must agree to use at least one medically approved contraceptive measure (such as surgical sterilization, oral contraceptives, intrauterine devices, sexual desire control, etc.) during the study treatment and at least 6 months after the last trial drug treatment;
* Subjects voluntarily participated in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
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.
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