Not yet recruiting NCT07590856

A Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33

Early Phase I Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: GPA33-CC；177Lu-SmartD2.
Who it may be relevant to: Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
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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

Overview

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.

Interventions

Drug GPA33-CC；177Lu-SmartD2
SNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion.

Primary outcome measures

To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer. [Time frame: 3 weeks]
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer. [Time frame: 3 weeks]
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer. [Time frame: 3 weeks]
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer. [Time frame: 3 weeks]
To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer. [Time frame: 3 weeks]
To evaluate the pharmacokinetic of the GPA33-CC protein [Time frame: up to 1 week]
To evaluate the pharmacokinetic of the GPA33-CC protein [Time frame: up to 1 week]
To evaluate the pharmacokinetic of the GPA33-CC protein [Time frame: up to 1 week]
To evaluate the radiological characteristics 177Lu-SmartD2. [Time frame: up to 1 week]

Secondary outcome measures (5)

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]

Eligibility criteria

Inclusion criteria

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:

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

China · 1 center

Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07590856 · SNA028-202601

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗