ImmunoPET Imaging of Pancreatic Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

[89Zr]Zr-DFO-SHR1920: Enrolled pancreatic cancer patients will receive a single dose (1-3mCi) of \[89Zr\]Zr-DFO-SHR1920 (total 1-2mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

[18F]F-RESCA-3A12: Enrolled pancreatic cancer patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-3A12. ImmunoPET/CT imaging will be acquired 1h after \[18F\]F-RESCA-3A12 injection.

[68Ga]Ga-NOTA-3A12: Enrolled pancreatic cancer patients will receive 0.05-0.1mCi/kg of \[68Ga\]Ga-NOTA-3A12. ImmunoPET/CT imaging will be acquired 1h after \[68Ga\]Ga-NOTA-3A12 injection.

Study summary

Pancreatic cancer remains one of the most aggressive cancer types. Target-specific targeted therapy is an attractive therapeutic alternative for the treatment of patients with a wide range of cancers, including pancreatic cancer. Companion diagnostic technique is critical for the success of targeted therapies. SHR-A1921 is a TROP2-directed antibody-drug-conjugate (ADC) approved for several clinical trials for advanced solid tumors. SHR1920 is the humanized anti-Trop2 monoclonal antibody (hIgG1) of SHR-A1921. Radio-labeling SHR1920 with radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of SHR-A1921 distribution in cancer patients. Performing a \[89Zr\]Zr-DFO-SHR1920 PET scan before treatment with SHR-A1921 can evaluate tracer uptake in the primary and metastatic tumor lesions and normal organ distribution. CLND18.2 is another potential therapeutic target for pancreatic cancer. Target-specific immunoPET imaging may help identify patients more likely to benefit from targeted therapy.

Eligibility

Primary outcome measure(s)

• SUV — 7 days
  Standardized uptake value (SUV) of \[89Zr\]Zr-DFO-SHR1920、\[18F\]F-RESCA-3A12 or \[68Ga\]Ga-NOTA-3A12 for each primary tumor of subject or suspected metastasis.
• Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920 — 7 days
  Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq).

Trial sites (1)

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