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Preliminary Trial of SNA014 for Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSmartNuclide Biopharma

About this trial

68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 75 years (inclusive);

Possessing legal capacity, voluntarily participating in this clinical trial, and having signed the informed consent form (ICF);

Patients with a confirmed diagnosis of pancreatic cancer whose tumours are suitable for Claudin-18.2 testing;

Results of gastroscopy, CT, MRI or PET-CT scans performed within the past month (if available);

Disqualifiers

Patients with other clearly diagnosed malignant tumours;

Patients with uncontrolled severe infections, or those with other serious comorbidities;

Patients with a life expectancy of ≤3 months;

Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial;

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-NODAGA-SNA006

    Drug

    Administration

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The safety and tolerability profile of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

Occurrence of AE/SAE according to CTCAE 5.0

Time frame
1 week
2

CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

SUVmax of tumors

Time frame
1 week
3

CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

SUVmean of tumors

Time frame
1 week
4

CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

Correlation of tumor uptakes and Immunohistochemistry

Time frame
1 week

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SmartNuclide Biopharma

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Source ClinicalTrials.gov
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