TheranosticTrials.org

Clinical Trial · NCT07595237

A IIT Study of 177Lu-DOTA-SNA040

Overview

This clinical trial is a single-center, open-label, non-randomized, first-in-human (FIH), dose-escalation study evaluating the safety, tolerability, and preliminary efficacy of 177Lu-DOTA-SNA040 in patients with advanced Claudin18.2-positive solid tumors (e.g., gastric cancer, gastroesophageal junction adenocarcinoma, pancreatic cancer, cholangiocarcinoma, etc.) who have disease progression following first-line therapy.

Sponsor

SmartNuclide Biopharma

Phase

Early Phase 1

Contacts

shaoli song, doctor (CONTACT)

mengru.wu@smartnucl.com

0512-67229125

ClinicalTrials.gov

NCT07595237

Drug / Compound

NODAGA-SNA014

Isotope(s):
Target(s):
  • Claudin 18.2
Chelator: NODAGA

DOTA-SNA040

Isotope(s):
Target(s):
  • Claudin 18.2
Chelator: DOTA

Eligibility

Inclusion

  • 1. Age range of 18 to 75 years old (including boundary values);
  • Patients with advanced solid tumors confirmed by histopathology or cytology (such as gastric cancer or adenocarcinoma at the gastroesophageal junction, pancreatic cancer, and cholangiocarcinoma) and confirmed by the investigator, who fail to receive first-line treatment or have disease progression; According to RECIST 1.1 definition, there must be at least one measurable lesion;7\. At least one lesion must be immunohistochemistry positive for Claudin18.2 (≥ 20% of tumor cells have Claudin18.2 immunohistochemistry membrane staining intensity ≥ 2+); Before the first administration of 177Lu-DOTA-SNA040 treatment, the toxicity caused by previous treatments must be restored to ≤ level 2 (CTCAE V5.0) or a stable state evaluated by the researcher (excluding hair loss and pigmentation); 177Lu DOTA-SNA040 has sufficient organ function one week before treatment, defined as follows:
  • Life expectancy\>6 months;
  • 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);

Exclusion

  • Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before treatment with 177Lu DOTA-SNA040;
  • 1. The nutritional status is extremely poor, with a BMI of less than 18.5 during screening, and the subjects cannot tolerate the test;
  • 177Lu DOTA-SNA040 patients who received antibody conjugated drug (ADC) treatment 4 weeks before treatment;
  • Those who have received other experimental anti-tumor drug treatments 4 weeks before 177Lu DOTA-SNA040 treatment;
  • Individuals who have previously been allergic to 177Lu DOTA-SNA040 or its analogues;