A IIT Study of 177Lu-DOTA-SNA040

NCT07595237 | Recruiting Early Phase 1

• 1 other identifier: SNA040-202501
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

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)

Keywords

Claudin18.2; 177Lu-DOTA-SNA040

Outcome Measures

Primary Outcomes (6)

• Dose-limiting toxicity(DLT) of the single dose

  Occurance of DLT in the first cycle of each group

  4 to 6weeks

• The safety and tolerance of 177Lu-DOTA-SNA040

  The occurance and stage of AE and SAE according to CTCAE

  4 to 6 weeks

• The safety and tolerance of 177Lu-DOTA-SNA040

  The rates of abnormal laborotary tests after administration

  4 to 6 weeks

• The safety and tolerance of 177Lu-DOTA-SNA040

  The rates of abnormal vital signs after administration

  4 to 6 weeks

• The safety and tolerance of 177Lu-DOTA-SNA040

  The rates of abnormal physical examination after administration

  4 to 6 weeks

• The safety and tolerance of 177Lu-DOTA-SNA040

  The rates of abnormal 12-lead ECG after administration

  4 to 6 weeks

Secondary Outcomes (15)

• The biodistribution of SNA040

  1 week

• The tumor uptake of SNA040

  1 week

• The tumor uptake of SNA040

  1 week

• The tumor uptake of SNA040

  1 week

• To evaluate the radiological characteristics 177Lu-DOTA-SNA040

  1 week

Study Arms (4)

Group 1

EXPERIMENTAL

30\~70mCi

Drug: 177Lu-DOTA-SNA040

Group 2

EXPERIMENTAL

100mCi

Drug: 177Lu-DOTA-SNA040

Group 3

EXPERIMENTAL

150mCi

Drug: 177Lu-DOTA-SNA040

Group 4

EXPERIMENTAL

200mCi

Drug: 177Lu-DOTA-SNA040

Interventions

177Lu-DOTA-SNA040 DRUG

177Lu-DOTA-SNA040 administration

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• \. 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:
• Bone marrow:
• White blood cell count range from 3.0 to 10.0 × 10\^9/L Absolute neutrophil count range from 1.5 to 7.0 × 10\^9/L Platelets range from 75 to 300 × 10\^9/L Hemoglobin ≥ 90g/L
• Liver:
• Total bilirubin ≤ 2.5 x upper limit of normal (ULN) Serum albumin\>3.0 g/dL Alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN or liver metastasis patients ≤ 5 × ULN
• Kidney:
• Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft Gault formula)
• Coagulation function The international standardized ratio of prothrombin is less than 1.5 × ULN Prothrombin time\<2 × ULN During the treatment with 177Lu-DOTA-SNA040, the best support/standard of care agreed upon by the researcher is allowed; 11. Patients and/or partners with fertility must use adequate contraceptive measures during the study period and within 6 months after the last administration of the study drug.

You may not qualify if:

• 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;
• Lu 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 known to have central nervous system metastases and/or malignant meningitis;
• Major comorbidities: including but not limited to New York Heart Association grade III or IV congestive heart failure, a history of congenital QT interval prolongation syndrome, active severe infections, or other major diseases that the researcher deems unsuitable for participation in the study;
• Patients with obvious gastric bleeding and/or untreated gastric ulcers;
• Diagnosed with other malignant tumors that may alter life expectancy or interfere with disease assessment;
• Pregnant or lactating women;
• The researcher believes that they are not suitable to participate in this clinical study.

Sponsors & Collaborators

• SmartNuclide Biopharma: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

shaoli song, doctor

CONTACT

0512-67229125; mengru.wu@smartnucl.com

Study Design

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

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: May 19, 2026
• Study Start: November 1, 2025
• Primary Completion: November 24, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

CN (1)