NCT07597759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for early_phase_1 colorectal-cancer

Timeline
Completed

Started Oct 2025

Shorter than P25 for early_phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 21, 2026

Last Update Submit

May 13, 2026

Conditions

Colorectal CancerGPA33

Keywords

Colorectal cancerGPA33Radiopharmaceuticals

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (1)

  • Correlation between imaging and IHC

    4 hours

Study Arms (4)

Group1

EXPERIMENTAL

0.1mg

Drug: 68Ga-NODAGA-SNA009

Group 2

EXPERIMENTAL

0.3mg

Drug: 68Ga-NODAGA-SNA009

Group 3

EXPERIMENTAL

0.5mg

Drug: 68Ga-NODAGA-SNA009

Group 4

EXPERIMENTAL

0.9mg

Drug: 68Ga-NODAGA-SNA009

Interventions

68Ga-NODAGA-SNA009DRUG

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

Group 2Group 3Group 4Group1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 75 years (inclusive);
  • Participants must have legal capacity, voluntarily agree to participate in this clinical trial, and have signed an informed consent form (ICF);
  • Patients with a confirmed diagnosis of colorectal cancer;
  • Results of colonoscopy, CT, MRI or PET-CT scans performed within the past month (if available);
  • Pathology test results from within the past year

You may not qualify if:

  • Patients with other clearly diagnosed malignant tumours;
  • Patients with uncontrolled severe infections, or those with other serious comorbidities;
  • Patients with a life expectancy of ≤3 months;
  • Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial;
  • Patients deemed unsuitable for participation in this study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 19, 2026

Study Start

October 30, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 19, 2026

Record last verified: 2026-04

Locations

CN(1)