Actively Recruiting
Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer
Led by Tongji Hospital · Updated on 2024-08-13
30
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
Q
Qilu Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytopathology confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, except mucinous cancer.
- Relapsed or refractory disease after at least one standard platinum-containing chemotherapy regimen.
- Evidence of disease relapse based on imaging or clinical progression (not solely CA125 increase).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Toxicities from prior therapies resolved to Grade 1 or baseline, except alopecia, pigmentation, or non-safety risk toxicities.
- At least one measurable target lesion by RECIST 1.1 criteria.
- Adequate kidney, liver, bone marrow, coagulation, and immune function.
- Negative pregnancy test within 14 days before treatment.
- Agreement to use medically approved contraception during treatment and for 6 months after last trial drug.
- Voluntary participation with signed informed consent and willingness to comply with study follow-up.
You will not qualify if you...
- Central nervous system metastasis or cancerous meningitis (unless neurologically stable for 3 months).
- Other active malignancies within 3 years except locally curable cancers.
- Surgery grade II or above within 4 weeks except minimally invasive gastrointestinal endoscopy surgery.
- Radiotherapy within 2 weeks prior to enrollment.
- Participation in other therapeutic clinical studies or local anti-tumor treatment within 4 weeks.
- Allergy to study drug or components.
- History of severe allergic reaction to smallpox vaccine.
- Severe skin diseases requiring systemic treatment within 2 years.
- History of allogenic tissue or organ transplant.
- Active infection or fever above 38.5°C.
- Active pulmonary tuberculosis under treatment or treated within 1 year.
- Positive for HIV, HCV, syphilis antibodies, or active hepatitis B.
- Serious cardiovascular or cerebrovascular diseases including severe heart failure, arrhythmias, recent myocardial infarction, low ejection fraction, prolonged QTcF interval, or uncontrolled hypertension.
- Active autoimmune diseases except controlled type I diabetes, hypothyroidism, or mild skin diseases not requiring systemic treatment.
- Symptomatic malignant ascites or pleural effusions requiring frequent drainage.
- Contraindications to intraperitoneal catheter placement.
- Active gastrointestinal bleeding.
- Unstable mental illness, alcohol or drug abuse.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qinglei Gao, MD. PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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