Phase IIT Trial of SNA009

A Clinical Study Evaluating the Safety, Tolerability, Biodistribution and Radiation Dose Measurement of 68Ga-NODAGA-SNA009 in Patients With Colorectal Cancer

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07597759

Enrollment

Registered

2026-05-19

Start date

2025-10-30

Completion date

2025-12-31

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, GPA33

Keywords

Colorectal cancer, GPA33, Radiopharmaceuticals

Brief summary

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.

Detailed description

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.

Interventions

DRUG68Ga-NODAGA-SNA009

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The safety and tolerability in patients with advanced colorectal cancer.	1 week	Occurrence of AE/SAE according to CTCAE 5.0
The radiation characters in patients with colorectal cancer	4 hours	radiological absorption dose of major organs
The biodistribution characteristics of 68Ga-NODAGA-SNA009	4 hours	SUVmax of major organs and tumors

Secondary

Measure	Time frame	Description
Correlation between imaging and IHC	4 hours	Correlation of tumors between 68Ga-NODAGA-SNA009 in PET imaging and GPA33 expression levels in patients with colorectal cancer.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026