A IIT Study of 177Lu-DOTA-SNA040

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSmartNuclide Biopharma

About this trial

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.

Eligibility criteria

Qualifiers

Age range of 18 to 75 years old (including boundary values);

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;

Disqualifiers

The nutritional status is extremely poor, with a BMI of less than 18.5 during screening, and the subjects cannot tolerate the test;

Individuals who have previously been allergic to 177Lu DOTA-SNA040 or its analogues;

Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before treatment with 177Lu DOTA-SNA040;

177Lu DOTA-SNA040 patients who received antibody conjugated drug (ADC) treatment 4 weeks before treatment;

Trial design

Treatments tested in this trial

  • 177Lu-DOTA-SNA040

Treatment groups

12 Participants
are divided into 4 treatment groups

Sponsors and collaborators