A Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33
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
1 other identifier
interventional
20
1 country
1
Brief 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 patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 colorectal-cancer
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 15, 2026
May 1, 2026
1.6 years
April 17, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of AE/SAE after administration
3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Laboratory tests after administration
3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Vital signs after administration
3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal Physical examination after administration
3 weeks
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.
Occurrence of abnormal ECG after administration
3 weeks
To evaluate the pharmacokinetic of the GPA33-CC protein
Peak plasma concentration (Cmax) of the GPA33-CC
up to 1 week
To evaluate the pharmacokinetic of the GPA33-CC protein
half-life (t1/2) of the GPA33-CC
up to 1 week
To evaluate the pharmacokinetic of the GPA33-CC protein
Area under the concentration-time curve (AUC) of the GPA33-CC
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.
up to 1 week
Secondary Outcomes (5)
To evaluate the biodistribution of SNA028
up to 2 weeks
To evaluate the biodistribution of SNA028
up to 2 weeks
To evaluate the biodistribution of SNA028
up to 2 weeks
To evaluate the biodistribution of SNA028
up to 2 weeks
Assessment of the immunogenicity of GPA33-CC
4 weeks
Other Outcomes (5)
Assessing tumour response according to RECIST1.1
every 6 weeks up to 2 years
Assessing tumour response according to RECIST1.1
Every 6 weeks up to 2 years
Assessing tumour response according to RECIST1.1
every 6 weeks up to 2 years
- +2 more other outcomes
Study Arms (7)
Dose group 1
EXPERIMENTALGPA33-CC protein dosage 0.3mg/kg The interval is 7d and the mass dose of SmartD2 is 60nmol
Dose group 2
EXPERIMENTALGPA33-CC protein dosage 1mg/kg. The interval is 7d and the mass dose of SmartD2 is 60nmol
Dose group 3
EXPERIMENTALGPA33-CC protein dosage 3mg/kg. The interval is 7d and the mass dose of SmartD2 is 60nmol
Dose group 4
EXPERIMENTALThe interval is 3d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage
Dose group 5
EXPERIMENTALThe interval is 5d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage
Dose group 6
EXPERIMENTALThe mass dose of SmartD2 is 120nmol with optimal GPA33-CC protein dosage and interval.
Dose group 7
EXPERIMENTALThe mass dose of SmartD2 is 200nmol with optimal GPA33-CC protein dosage and interval.
Interventions
SNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion.
Eligibility Criteria
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 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;
- 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:
- \) 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
- +4 more criteria
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
April 17, 2026
First Posted
May 15, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05