68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy

NCT05000372 | Completed Phase 1 DMC

• 1 other identifier: 2021KT86
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.

Conditions

Cancer

Keywords

PET/CT; Immunotherapy; Immune checkpoint inhibition; Granzyme B; 68Ga labeling

Outcome Measures

Primary Outcomes (4)

• Incidence of 68Ga-grazytracer-emergent Adverse Events

  Any adverse events following the administration of the radiotracer will be monitored.

  3 year

• Biodistribution of 68Ga-grazytracer

  The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.

  3 year

• Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer

  The specificity of 68Ga-grazytracer will be validated by correlating the immunohistochemistry results of granzyme B in either surgical or biopsy tissue samples with the standardized uptake values (SUV) of 68Ga-grazytracer in the tumors.

  3 year

• Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response

  Participants will be categorized into groups with high or low 68Ga-grazytracer uptake in tumor lesions. The progression-free survival and treatment response, as assessed by RECIST 1.1 criteria, will be compared across these groups.

  3 year

Secondary Outcomes (1)

• Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype

  3 year

Study Arms (1)

Feasibility and safety of 68Ga-grazytracer

EXPERIMENTAL

The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy.

Drug: 68Ga-grazytracer

Interventions

68Ga-grazytracer DRUG

68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh.

Feasibility and safety of 68Ga-grazytracer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who were diagnosed with malignant tumors;
• Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
• participants who had no prior immunotherapy;
• participants who had no regional therapy within 3 months;
• Participants aged ≥18 years.

You may not qualify if:

• participants with a concurrent disease that would impede the treatment regimen;
• Participants who were unable or unwilling to provide written informed consent.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Peking University Health Science Center: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (2)

• Shen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2.

  PMID: 39389969 DERIVED

• Zhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065.

  PMID: 35788116 DERIVED

MeSH Terms

Conditions

Neoplasms; Lipodystrophy, Congenital Generalized

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nan Li, M.D.

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

• Zhaofei Liu, Ph.D.

  Peking University

  STUDY DIRECTOR

• Zhi Yang, Ph.D.

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 11, 2021
• Study Start: September 22, 2021
• Primary Completion: May 25, 2024
• Study Completion: May 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)