Advanced Solid Tumors (Such as Gastric Cancer)Early Phase 1NCT07595237
A IIT Study of 177Lu-DOTA-SNA040
A Early Phase 1 study testing 177Lu-DOTA-SNA040 in people with Advanced Solid Tumors (Such as Gastric Cancer) and Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction), run by SmartNuclide Biopharma at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors (Such as Gastric Cancer), Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction), Advanced Solid Tumors (Such as Pancreatic Cancer)
- What is being tested?
- 177Lu-DOTA-SNA040
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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:
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- 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.
Who cannot join
- 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;
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Shaoli Song, PhD, shaoli-song@163.com
About this study
Official title: 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
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.
Read the detailed description
Eligible subjects should first undergo 68Ga-NODAGA-SNA014 PET/CT imaging. Patients with negative 68Ga-NODAGA-SNA014 tumor uptake will be discharged from the study after one week of follow-up for adverse events. Patients with positive 68Ga-NODAGA-SNA014 tumor uptake (SUVmax ≥10) will proceed to the subsequent 177Lu-DOTA-SNA040 dose escalation study (with at least a 2-day interval between 68Ga-NODAGA-SNA014 imaging and 177Lu-DOTA-SNA040 treatment). After completing the first cycle of dosing for DLT observation, subsequent 2-6 cycles of 177Lu-DOTA-SNA040 treatment may be administered. For dose group 1, the subsequent 2-6 cycles of 177Lu-DOTA-SNA040 dosing activity will be determined by the investigator, with the dose per cycle adjustable. For dose groups 2-4, the 177Lu-DOTA-SNA040 dosing activity will follow the fixed original dose (e.g., the first cycle dose for dose group 2 is 100 mCi, with subsequent 2-6 cycles fixed at 100 mCi).
- 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)
- Being tested
- 177Lu-DOTA-SNA040
- Keywords
- Claudin18.2, 177Lu-DOTA-SNA040
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTA-SNA040Drug
177Lu-DOTA-SNA040 administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 30~70mCi Receives: Drug: 177Lu-DOTA-SNA040 |
| Group 2 | Experimental | 100mCi Receives: Drug: 177Lu-DOTA-SNA040 |
| Group 3 | Experimental | 150mCi Receives: Drug: 177Lu-DOTA-SNA040 |
| Group 4 | Experimental | 200mCi Receives: Drug: 177Lu-DOTA-SNA040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT) of the single dose
Occurance of DLT in the first cycle of each group
Measured: 4 to 6weeks
The safety and tolerance of 177Lu-DOTA-SNA040
The occurance and stage of AE and SAE according to CTCAE
Measured: 4 to 6 weeks
The safety and tolerance of 177Lu-DOTA-SNA040
The rates of abnormal laborotary tests after administration
Measured: 4 to 6 weeks
The safety and tolerance of 177Lu-DOTA-SNA040
The rates of abnormal vital signs after administration
Measured: 4 to 6 weeks
The safety and tolerance of 177Lu-DOTA-SNA040
The rates of abnormal physical examination after administration
Measured: 4 to 6 weeks
The safety and tolerance of 177Lu-DOTA-SNA040
The rates of abnormal 12-lead ECG after administration
Measured: 4 to 6 weeks
Secondary outcomes (15)
The biodistribution of SNA040
Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)
Measured: 1 week
The tumor uptake of SNA040
SUVmax and SUVmean of tumor
Measured: 1 week
The tumor uptake of SNA040
The retention time of tumor
Measured: 1 week
The tumor uptake of SNA040
The ID% of tumor
Measured: 1 week
To evaluate the radiological characteristics 177Lu-DOTA-SNA040
Rradiation doses in whole blood, serum, urine measured using a gamma counter
Measured: 1 week
The pharmacokinetic of the SNA040 protein
Peak plasma concentration (Cmax) of the SNA040
Measured: 1 week
The pharmacokinetic of the SNA040 protein
Area under the concentration-time curve (AUC) of the SNA040
Measured: 1 week
The pharmacokinetic of the SNA040 protein
Clearance (CL) of the SNA040
Measured: 1 week
Assessment of the immunogenicity of SNA040
Occurance of positive immunogenicity test
Measured: 1 week
Assessing tumour response according to RECIST1.1
The DCR of tumors
Measured: 4 to 6 weeks
Assessing tumour response according to RECIST1.1
The ORR of tumors
Measured: 4 to 6 weeks
Assessing tumour response according to RECIST1.1
The DOR of tumors
Measured: 4 to 6 weeks
Explore the PFS of subjects
PFS according to the RECIST1.1
Measured: 2 years
Explore the OS of subjects
Overall survival (OS) according to the RECIST1.1
Measured: 2 years
the correlation between the clinical efficacy of SNA040 and Claudin18.2 expression
the correlation between overall response and Immunohistochemistry expression of Claudin18.2
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Nov 2025
- Primary completion24 Nov 2025
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors (Such as Gastric Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SmartNuclide Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595237
- Sponsor's protocol ID
- SNA040-202501
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07595237
- Acronym / sponsor ID
- SNA040-202501
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects should first undergo 68Ga-NODAGA-SNA014 PET/CT imaging. Patients with negative 68Ga-NODAGA-SNA014 tumor uptake will be discharged from the study after one week of follow-up for adverse events. Patients with positive 68Ga-NODAGA-SNA014 tumor uptake (SUVmax ≥10) will proceed to the subsequent 177Lu-DOTA-SNA040 dose escalation study (with at least a 2-day interval between 68Ga-NODAGA-SNA014 imaging and 177Lu-DOTA-SNA040 treatment). After completing the first cycle of dosing for DLT observation, subsequent 2-6 cycles of 177Lu-DOTA-SNA040 treatment may be administered. For dose group 1, the subsequent 2-6 cycles of 177Lu-DOTA-SNA040 dosing activity will be determined by the investigator, with the dose per cycle adjustable. For dose groups 2-4, the 177Lu-DOTA-SNA040 dosing activity will follow the fixed original dose (e.g., the first cycle dose for dose group 2 is 100 mCi, with subsequent 2-6 cycles fixed at 100 mCi).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: 177Lu-DOTA-SNA04030~70mCi |
| Group 2 | Experimental | Drug: 177Lu-DOTA-SNA040100mCi |
| Group 3 | Experimental | Drug: 177Lu-DOTA-SNA040150mCi |
| Group 4 | Experimental | Drug: 177Lu-DOTA-SNA040200mCi |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
- Those who have received other experimental anti-tumor drug treatments 4 weeks before 177Lu DOTA-SNA040 treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-DOTA-SNA040177Lu-DOTA-SNA040 administration | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Dose-limiting toxicity(DLT) of the single dose
Time frame: 4 to 6weeks
Occurance of DLT in the first cycle of each group
The safety and tolerance of 177Lu-DOTA-SNA040
Time frame: 4 to 6 weeks
The occurance and stage of AE and SAE according to CTCAE
The safety and tolerance of 177Lu-DOTA-SNA040
Time frame: 4 to 6 weeks
The rates of abnormal laborotary tests after administration
The safety and tolerance of 177Lu-DOTA-SNA040
Time frame: 4 to 6 weeks
The rates of abnormal vital signs after administration
The safety and tolerance of 177Lu-DOTA-SNA040
Time frame: 4 to 6 weeks
The rates of abnormal physical examination after administration
The safety and tolerance of 177Lu-DOTA-SNA040
Time frame: 4 to 6 weeks
The rates of abnormal 12-lead ECG after administration
15 secondary outcomes
The biodistribution of SNA040
Time frame: 1 week
The tumor uptake of SNA040
Time frame: 1 week
The tumor uptake of SNA040
Time frame: 1 week
The tumor uptake of SNA040
Time frame: 1 week
To evaluate the radiological characteristics 177Lu-DOTA-SNA040
Time frame: 1 week
The pharmacokinetic of the SNA040 protein
Time frame: 1 week
The pharmacokinetic of the SNA040 protein
Time frame: 1 week
The pharmacokinetic of the SNA040 protein
Time frame: 1 week
Assessment of the immunogenicity of SNA040
Time frame: 1 week
Assessing tumour response according to RECIST1.1
Time frame: 4 to 6 weeks
Assessing tumour response according to RECIST1.1
Time frame: 4 to 6 weeks
Assessing tumour response according to RECIST1.1
Time frame: 4 to 6 weeks
Explore the PFS of subjects
Time frame: 2 years
Explore the OS of subjects
Time frame: 2 years
the correlation between the clinical efficacy of SNA040 and Claudin18.2 expression
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 177Lu-DOTA-SNA040 in people with Advanced Solid Tumors (Such as Gastric Cancer) and Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction), run by SmartNuclide Biopharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaoli song, doctor (0512-67229125, mr.wu@smartnucl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity(DLT) of the single dose (time frame: 4 to 6weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.