Clinical trial NCT05856643: Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma
Official title: Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Ovarian Epithelial Carcinoma
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
Collaborators: name: Guangdong ProCapZoom Biosciences Co., Ltd.
First posted: 2023-05-12
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of ovarian epithelial carcinoma


Eligibility criteria: Inclusion Criteria:

1. Females aged 18-80;
2. Histologically confirmed ovarian epithelial carcinoma;
3. Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;
4. At least one measurable lesion according to RECIST 1.1 ;
5. Positive expression of mesothelin in ovarian cancer tumors;
6. Functional status score (KPS) ≥80;
7. Expected survival ≥28 weeks;
8. The function of important organs meets the following requirements: absolute neutrophil count ≥1.5×109/L; platelets count ≥50×109/L; hemoglobin ≥80g/L; serum albumin ≥2.5g/dL; bilirubin ≤1.5 times ULN; ALT and AST ≤3 times ULN; serum creatinine ≤1.5 times ULN;
9. Able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
10. The subject or their partner agrees to take the contraceptive measures recognized by the trial within 1 month after signing the informed consent form until the end of the study.

Exclusion Criteria:

1. Exclusion criteria include those who have had other malignant tumors within the past 5 years, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has not recurred for \>3 years after radical surgery.
2. Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.
3. Patients who have experienced arterial thromboembolic events (including myocardial infarction, cardiac arrest, cerebrovascular accident, ischemic stroke, deep venous thrombosis of CTCAE 5.0 grade ≥3) or a history of pulmonary embolism within 6 months prior to enrollment are excluded.
4. Patients with a history of serious bleeding disorder within 6 months prior to screening, or those with a clear tendency to bleed (such as esophageal varices at risk of bleeding, active ulcer lesions, fecal occult blood \>2+) as judged by the investigator, are excluded.
5. Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.
6. Patients with clinically significant cardiovascular disease:

   1. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110mmHg) despite treatment;
   2. History of myocardial infarction or unstable angina pectoris within 6 months prior to enrollment;
   3. Congestive heart failure or NYHA class II heart failure;
   4. Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial fibrillation that is controllable.
7. Pregnant or lactating women are excluded.
8. Those who have participated in or are currently participating in other clinical trials within the past three months are excluded.
9. Patients considered unsuitable for this clinical trial by the investigator are excluded.

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: Up to 6 months after infusion
measure: Objective response rate (ORR)
timeFrame: Up to 6 months after infusion
measure: Overall survival (OS)
timeFrame: Up to 6 months after infusion
measure: Progression-free survival (PFS)
timeFrame: Up to 6 months after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Shantou University Medical College
state: Guangdong
Study officials:
References: