CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: 18F-FDG

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hua Zhu; Phone Number: 010-88196495; Email: zhuhuaBCH@pku.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Hua Zhu; Phone Number: 010-88196495; Email: zhuhuaBCH@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Aged >18 years old; ECOG 0 or 1;
• 2. Patients with solid tumors;
• 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
• 4. life expectancy >=12 weeks.

Exclusion Criteria:

• 1. Significant hepatic or renal dysfunction;
• 2. Is pregnant or ready to pregnant;
• 3. Cannot keep their states for half an hour;
• 4. Refusal to join the clinical study;
• 5. Suffering from claustrophobia or other mental diseases;
• 6. Any other situation that researchers think it is not suitable to participate in the experiment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-ACN376; Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.	Drug: 18F-FDG; All study participants will undergo one 18F-FDG PET/CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized uptake value（SUV）	SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-ACN376） in solid tumor lesions by measuring SUV on PET/CT.	2 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Hua Zhu, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Carbohydrates; Deoxyglucose; Deoxy Sugars; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2022KT96

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No