Clinical Trial · NCT07590856

A Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33

Overview

This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.

Sponsor

SmartNuclide Biopharma

Phase

Early Phase 1

Contacts

Dong Dai, Doctor (CONTACT)

1014481959@qq.com

0512-23340123

ClinicalTrials.gov

NCT07590856

Drug / Compound

SNA028

Isotope(s):

Target(s):

Glycoprotein A33 (GPA33)

Eligibility

Inclusion

Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
Individuals with ECOG scores ranging from 0 to 1 (see Appendix 1 for details);
Life expectancy\>6 months;
Patients with colorectal cancer diagnosed by histopathology or cytology and experiencing imaging progression/recurrence after standard treatment;
1. Age range of 18 to 75 years old (including boundary values);

Exclusion

Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;
1. Poor nutritional status and inability to tolerate the test subjects;
Individuals who have previously been allergic to SNA028 components or their analogues;
Patients who received anti-GPA33 antibody treatment 4 weeks before SNA028 treatment;
Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;