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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; GPA33
• Intervention / Treatment: Drug: 68Ga-NODAGA-SNA009

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300000
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1; 0.1mg	Drug: 68Ga-NODAGA-SNA009; 68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
Experimental: Group 2; 0.3mg	Drug: 68Ga-NODAGA-SNA009; 68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
Experimental: Group 3; 0.5mg	Drug: 68Ga-NODAGA-SNA009; 68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
Experimental: Group 4; 0.9mg	Drug: 68Ga-NODAGA-SNA009; 68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety and tolerability in patients with advanced colorectal cancer.	Occurrence of AE/SAE according to CTCAE 5.0	1 week
The safety and tolerability in patients with advanced colorectal cancer.	Occurrence of abnormal Laboratory tests after administration	1 week
The safety and tolerability in patients with advanced colorectal cancer.	Occurrence of abnormal Vital signs after administration	1 week
The safety and tolerability in patients with advanced colorectal cancer.	Occurrence of abnormal Physical examination after administration	1 week
The safety and tolerability in patients with advanced colorectal cancer.	Occurrence of abnormal ECG after administration	1 week
The radiation characters in patients with colorectal cancer	radiological absorption dose of major organs	4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009	SUVmax of major organs and tumors	4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009	SUVmean of major organs and tumors	4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009	Retention time of major organs and tumors	4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009	Percentage of injection dose (ID%) of major organs and tumors	4 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SmartNuclide Biopharma
• Collaborators: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal cancer; Radiopharmaceuticals; GPA33
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SNA009-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No