PD-L2 Targeting Nanobody Radiotracer for PET Imaging of Solid Tumor

NCT ID: NCT05803746

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2024-07-15

Brief Summary

The objective of this study is to construct a noninvasive approach using 68Ga- Mirc415 PET/CT to detect the PD-L2 expression of tumor lesion in patients with colorectal cancer, lung cancer and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.

Conditions

Lung Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Imaging cohort

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-Mirc415 PET/CT scan.

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: DRUG

All study participants will undergo one 18F-FDG PET/ CT scan.

Interventions

18F-FDG

All study participants will undergo one 18F-FDG PET/ CT scan.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18-75, male and female, with ECOG score of 0 or 1;

2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);

3. The expected survival was more than 26 weeks;

4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;

5. According to RECIST1.1, there was at least one measurable target lesion;

6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;

7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria

1. The function of liver and kidney was seriously abnormal;

2. Preparation for pregnant, pregnant and lactating women;

3. Inability to lie flat for half an hour;

4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Hua Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhi Yang

Role: CONTACT

pekyz@163.com

010-88196196

Hua Zhu

Role: CONTACT

zhuhuabch@pku.edu.cn

010-88196495

Facility Contacts

Hua Zhu

Role: primary

zhuhuabch@pku.edu.cn

010-88196495

Other Identifiers

2022KT114

Identifier Type: -

Identifier Source: org_study_id