Phase IIT Trial of SNA009

Early Phase 1CompletedNCT07597759

SmartNuclide Biopharma12 enrolled

Overview

This clinical trial is a single-center, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and radiation dosimetry of 68Ga-NODAGA-SNA009 in patients with colorectal cancer.

68Ga-NODAGA-SNA009 is a radiopharmaceutical that targets GPA33. This study aims to assess the correlation between radiological imaging results and the pathological expression of GPA33.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Colorectal Cancer GPA33

Interventions

68Ga-NODAGA-SNA009DRUG

68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 75 years (inclusive); 2. Participants must have legal capacity, voluntarily agree to participate in this clinical trial, and have signed an informed consent form (ICF); 3. Patients with a confirmed diagnosis of colorectal cancer; 4. Results of colonoscopy, CT, MRI or PET-CT scans performed within the past month (if available); 5. Pathology test results from within the past year Exclusion Criteria: 1. Patients with other clearly diagnosed malignant tumours; 2. Patients with uncontrolled severe infections, or those with other serious comorbidities; 3. Patients with a life expectancy of ≤3 months; 4. Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial; 5. Patients deemed unsuitable for participation in this study by the investigator.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China