RecruitingEarly Phase 1NCT07595237

A IIT Study of 177Lu-DOTA-SNA040

A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Dose Determination, and Preliminary Efficacy of ¹⁷⁷Lu-DOTA-SNA040 in Patients With Claudin 18.2-positive Advanced Solid Tumors

Sponsor

SmartNuclide Biopharma

Enrollment

12 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors (Such as Gastric Cancer)Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction)Advanced Solid Tumors (Such as Pancreatic Cancer)Advanced Solid Tumors (Such as Cholangiocarcinoma)

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 177Lu-DOTA-SNA040 for people with advanced solid tumors (such as adenocarcinoma at the gastroesophageal junction), advanced solid tumors (such as cholangiocarcinoma), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-DOTA-SNA040

177Lu-DOTA-SNA040 administration

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07595237