ImmunoPET Imaging of Pancreatic Cancer

NCT06602037 | Recruiting DMC

• 1 other identifier: KY2024-067-C
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms Pancreatic

Keywords

Pancreatic cancer; ImmunoPET; Companion Diagnostics; Trop2; CLDN18.2（Claudin 18.2）; Gastric cancer; Solid tumors

Outcome Measures

Primary Outcomes (2)

• SUV

  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.

  7 days

• Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920

  Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq).

  7 days

Secondary Outcomes (3)

• Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV) and accuracy

  30 days

• Trop2 expression and SUV

  30 days

• CLDN18.2 expression and SUV

  30 days

Study Arms (1)

ImmunoPET imaging in patients with pancreatic cancers

EXPERIMENTAL

Enrolled pancreatic cancer patients (locally advanced or metastatic cancer) will undergo a Trop2/CLDN18.2-targeted immunoPET/CT scanning.

Diagnostic Test: [89Zr]Zr-DFO-SHR1920; Diagnostic Test: [18F]F-RESCA-3A12; Diagnostic Test: [68Ga]Ga-NOTA-3A12

Interventions

[18F]F-RESCA-3A12 DIAGNOSTIC_TEST

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.

Also known as: [18F]F-3A12

ImmunoPET imaging in patients with pancreatic cancers

[68Ga]Ga-NOTA-3A12 DIAGNOSTIC_TEST

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.

Also known as: [68Ga]Ga-3A12

ImmunoPET imaging in patients with pancreatic cancers

[89Zr]Zr-DFO-SHR1920 DIAGNOSTIC_TEST

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).

Also known as: [89Zr]Zr-SHR1920

ImmunoPET imaging in patients with pancreatic cancers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of pancreatic cancer or suspected pancreatic cancer by diagnostic imaging.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Known or suspected hypersensitivity to SHR1920, DFO/RESCA/NOTA, 89Zr/18F or 68Ga or any of the excipients.
• Pregnancy

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jianjun Liu, PhD

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

• Weijun Wei, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijun Wei, Ph.D. & M.D.

CONTACT

15000083153; wwei@shsmu.edu.cn

Shuxian An, Ph.D. & M.D.

CONTACT

17717453484; anshuxian@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CN (1)