Colorectal CancerEarly Phase 1NCT07590856
A Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33
A Early Phase 1 study testing GPA33-CC；177Lu-SmartD2 in people with Colorectal Cancer, 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) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- GPA33-CC；177Lu-SmartD2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Dec 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 colorectal cancer diagnosed by histopathology or cytology and experiencing imaging progression/recurrence after standard treatment;
- According to RECIST 1.1 definition, there must be at least one measurable lesion;
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- Toxicity caused by previous treatment must be restored to ≤ level 2 (CTCAE v6.0) or to a stable state evaluated by the researcher (excluding hair loss and pigmentation);
- Having sufficient organ function, defined as follows:
- 1) Bone marrow:
- White blood cell count 3.0~10.0 × 10^9/L
- Absolute neutrophil count 1.5~7.0 × 10^9/L
- Platelets 75~300 × 10^9/L
- Hemoglobin ≥ 90g/L 2) 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 3) Kidney:
- Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft Gault formula) 4) Coagulation function
- The international standardized ratio of prothrombin is less than 1.5 × ULN
- Prothrombin time<2 × ULN 9. 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
- Poor nutritional status and inability to tolerate the test subjects;
- Individuals who have previously been allergic to SNA028 components or their analogues;
- Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;
- Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;
- Patients who received anti-GPA33 antibody treatment 4 weeks before SNA028 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;
- 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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Single-center, Open-label, Non-randomized Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33
This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.
Read the detailed description
The trial is planned to explore three main topics: 1.the dose of GPA33-CC. 2. the intervation between administration of GPA33-CC Inervation and 177Lu-SmartD2. 3.the mass dose of SmartD2.
- Conditions
- Colorectal Cancer
- Being tested
- GPA33-CC；177Lu-SmartD2
- Keywords
- Colorectal cancer, GPA33, Radiopharmaceuticals, 177Lu
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPA33-CC；177Lu-SmartD2Drug
SNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dose group 1 | Experimental | GPA33-CC protein dosage 0.3mg/kg The interval is 7d and the mass dose of SmartD2 is 60nmol Receives: Drug: GPA33-CC；177Lu-SmartD2 |
| Dose group 2 | Experimental | GPA33-CC protein dosage 1mg/kg. The interval is 7d and the mass dose of SmartD2 is 60nmol Receives: Drug: GPA33-CC；177Lu-SmartD2 |
| Dose group 3 | Experimental | GPA33-CC protein dosage 3mg/kg. The interval is 7d and the mass dose of SmartD2 is 60nmol Receives: Drug: GPA33-CC；177Lu-SmartD2 |
| Dose group 4 | Experimental | The interval is 3d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage Receives: Drug: GPA33-CC；177Lu-SmartD2 |
| Dose group 5 | Experimental | The interval is 5d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage Receives: Drug: GPA33-CC；177Lu-SmartD2 |
| Dose group 6 | Experimental | The mass dose of SmartD2 is 120nmol with optimal GPA33-CC protein dosage and interval. Receives: Drug: GPA33-CC；177Lu-SmartD2 |
| Dose group 7 | Experimental | The mass dose of SmartD2 is 200nmol with optimal GPA33-CC protein dosage and interval. Receives: Drug: GPA33-CC；177Lu-SmartD2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of AE/SAE after administration
Measured: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Laboratory tests after administration
Measured: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Vital signs after administration
Measured: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Physical examination after administration
Measured: 3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal ECG after administration
Measured: 3 weeks
To evaluate the pharmacokinetic of the GPA33-CC protein
Peak plasma concentration (Cmax) of the GPA33-CC
Measured: up to 1 week
To evaluate the pharmacokinetic of the GPA33-CC protein
half-life (t1/2) of the GPA33-CC
Measured: up to 1 week
To evaluate the pharmacokinetic of the GPA33-CC protein
Area under the concentration-time curve (AUC) of the GPA33-CC
Measured: up to 1 week
To evaluate the radiological characteristics 177Lu-SmartD2.
Rradiation doses in whole blood and serum measured using a gamma counter radiological characteristics 177Lu-SmartD2 will be performed.
Measured: up to 1 week
Secondary outcomes (5)
To evaluate the biodistribution of SNA028
Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)
Measured: up to 2 weeks
To evaluate the biodistribution of SNA028
Major organ and tumour standardised uptake (SUVmax and SUVmean)
Measured: up to 2 weeks
To evaluate the biodistribution of SNA028
The retention time of major organs and tumor.
Measured: up to 2 weeks
To evaluate the biodistribution of SNA028
The tumour-to-background ratio (TBR) of SUV
Measured: up to 2 weeks
Assessment of the immunogenicity of GPA33-CC
Occurance of positive immunogenicity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 20 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
- NCT07590856
- Sponsor's protocol ID
- SNA028-202601
- Status last verified
- May 2026
- First submitted
- 17 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Non-randomized Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33
- ClinicalTrials.gov ID
- NCT07590856
- Acronym / sponsor ID
- SNA028-202601
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, GPA33, Radiopharmaceuticals, 177Lu
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 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) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.
Detailed description
The trial is planned to explore three main topics: 1.the dose of GPA33-CC. 2. the intervation between administration of GPA33-CC Inervation and 177Lu-SmartD2. 3.the mass dose of SmartD2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose group 1 | Experimental | Drug: GPA33-CC；177Lu-SmartD2GPA33-CC protein dosage 0.3mg/kg The interval is 7d and the mass dose of SmartD2 is 60nmol |
| Dose group 2 | Experimental | Drug: GPA33-CC；177Lu-SmartD2GPA33-CC protein dosage 1mg/kg. The interval is 7d and the mass dose of SmartD2 is 60nmol |
| Dose group 3 | Experimental | Drug: GPA33-CC；177Lu-SmartD2GPA33-CC protein dosage 3mg/kg. The interval is 7d and the mass dose of SmartD2 is 60nmol |
| Dose group 4 | Experimental | Drug: GPA33-CC；177Lu-SmartD2The interval is 3d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage |
| Dose group 5 | Experimental | Drug: GPA33-CC；177Lu-SmartD2The interval is 5d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage |
| Dose group 6 | Experimental | Drug: GPA33-CC；177Lu-SmartD2The mass dose of SmartD2 is 120nmol with optimal GPA33-CC protein dosage and interval. |
| Dose group 7 | Experimental | Drug: GPA33-CC；177Lu-SmartD2The mass dose of SmartD2 is 200nmol with optimal GPA33-CC protein dosage and interval. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 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 colorectal cancer diagnosed by histopathology or cytology and experiencing imaging progression/recurrence after standard treatment;
Key exclusion criteria (10 listed)
- Poor nutritional status and inability to tolerate the test subjects;
- Individuals who have previously been allergic to SNA028 components or their analogues;
- Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;
- Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;
- Patients who received anti-GPA33 antibody treatment 4 weeks before SNA028 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 |
|---|---|---|
| GPA33-CC；177Lu-SmartD2SNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion. | Drug | Dose group 1, Dose group 2, Dose group 3, Dose group 4, Dose group 5, Dose group 6, Dose group 7 |
Primary outcome
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Time frame: 3 weeks
Occurrence of AE/SAE after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Time frame: 3 weeks
Occurrence of abnormal Laboratory tests after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Time frame: 3 weeks
Occurrence of abnormal Vital signs after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Time frame: 3 weeks
Occurrence of abnormal Physical examination after administration
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Time frame: 3 weeks
Occurrence of abnormal ECG after administration
To evaluate the pharmacokinetic of the GPA33-CC protein
Time frame: up to 1 week
Peak plasma concentration (Cmax) of the GPA33-CC
To evaluate the pharmacokinetic of the GPA33-CC protein
Time frame: up to 1 week
half-life (t1/2) of the GPA33-CC
To evaluate the pharmacokinetic of the GPA33-CC protein
Time frame: up to 1 week
Area under the concentration-time curve (AUC) of the GPA33-CC
To evaluate the radiological characteristics 177Lu-SmartD2.
Time frame: up to 1 week
Rradiation doses in whole blood and serum measured using a gamma counter radiological characteristics 177Lu-SmartD2 will be performed.
5 secondary outcomes
To evaluate the biodistribution of SNA028
Time frame: up to 2 weeks
To evaluate the biodistribution of SNA028
Time frame: up to 2 weeks
To evaluate the biodistribution of SNA028
Time frame: up to 2 weeks
To evaluate the biodistribution of SNA028
Time frame: up to 2 weeks
Assessment of the immunogenicity of GPA33-CC
Time frame: 4 weeks
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 15 May 2026.
- Individual participant dataSharing planned: Undecided
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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 GPA33-CC；177Lu-SmartD2 in people with Colorectal Cancer, 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 19 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 May 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 Dong Dai, Doctor (0512-23340123 ext. 0512-23340123, 1014481959@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer. (time frame: 3 weeks). The study lists 9 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 15 May 2026.