NCT06383598

PD-L1 Specific [68Ga]Ga-THP-PDL1-3 Probe for PET Imaging in Solid Tumors

A First-in-human, Non-randomised, Single-arm Pilot and Feasibility Study of [68Ga]Ga-THP-PDL1-3 PET/CT in Patients With Solid Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hua Zhu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To utilize the \[68Ga\]Ga-THP-PDL1-3 molecular probe to non-invasively detect PD-L1 expression in primary and metastatic lesions of patients with solid tumors. Furthermore, to assess the heterogeneity of PD-L1 expression within the same lesion and across different lesions, and to observe changes in PD-L1 expression during the course of treatment. This approach aims to facilitate patient screening, therapeutic monitoring, and early warning of drug resistance and/or recurrence or metastasis in the treatment of solid tumors with high PD-L1 expression, ultimately enabling personalized targeted therapy in oncology.

Detailed description

Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	18F-FDG	All study participants will undergo one 18F-FDG PET/CT scan.
DRUG	[68Ga]Ga-THP-PDL1-3	\[68Ga\]Ga-THP-PDL1-3 is an investigational tracer, and all participants will undergo \[68Ga\]Ga-THP-PDL1-3 scanning.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-04-25
• Last updated: 2026-04-07

Locations

1 site across 1 country: China