Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
FEMALE
NCT05856643

Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma

Led by Shantou University Medical College · Updated on 2024-08-13

12

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

Sponsors

S

Shantou University Medical College

Lead Sponsor

G

Guangdong ProCapZoom Biosciences Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 80 years
  • Histologically confirmed ovarian epithelial carcinoma
  • Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments
  • At least one measurable lesion according to RECIST 1.1
  • Positive expression of mesothelin in ovarian cancer tumors
  • Karnofsky Performance Status (KPS) score of 80 or higher
  • Expected survival of 28 weeks or more
  • Adequate organ function: absolute neutrophil count 21.5 x 10^9/L; platelets 250 x 10^9/L; hemoglobin 280 g/L; serum albumin 2.5 g/dL; bilirubin 1.5 times upper limit of normal (ULN); ALT and AST 3 times ULN; serum creatinine 1.5 times ULN
  • Able to understand and voluntarily sign the informed consent form
  • Subject or partner agrees to use recognized contraceptive measures from consent until study end
Not Eligible

You will not qualify if you...

  • History of other malignant tumors within past 5 years, except cured basal cell carcinoma, cervical carcinoma in situ, and breast cancer without recurrence for more than 3 years after surgery
  • Known central nervous system metastasis or leptomeningeal disease
  • Arterial thromboembolic events or pulmonary embolism within 6 months prior to enrollment
  • Serious bleeding disorders within 6 months prior to screening or high bleeding risk
  • Congenital or acquired immunodeficiency, active hepatitis B or C, or severe infections
  • Clinically significant cardiovascular disease: uncontrolled hypertension, recent myocardial infarction or unstable angina, congestive heart failure NYHA class II, severe arrhythmia requiring medication (except controlled asymptomatic atrial fibrillation)
  • Pregnant or breastfeeding women
  • Participation in other clinical trials within past 3 months
  • Considered unsuitable for this clinical trial by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shantou University Medical College

Shantou, Guangdong, China

Actively Recruiting

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Research Team

C

ChongZhu Li, 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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Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma | DecenTrialz