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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: 18F-FDG; Drug: [68Ga]Ga-THP-PDL1-3

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-70 years, ECOG score 0 or 1;
2. Patients with solid tumors;
3. Presence of measurable lesions on imaging examinations;
4. Expected survival ≥12 weeks.

Exclusion Criteria:

1. Severe hepatic or renal dysfunction;
2. Women who are planning pregnancy, pregnant, or breastfeeding;
3. Unable to remain in supine position for 30 minutes;
4. Refusal to participate in this clinical study;
5. Diagnosis of claustrophobia or other psychiatric disorders;
6. Other conditions deemed by the investigator as inappropriate for participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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]Ga-THP-PDL1-3; All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]Ga-THP-PDL1-3 PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of [68Ga]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Feasibility	Adverse Event Number of participants with tracer-related adverse events.; Feasibility of PET/CT Imaging Number of participants in whom evaluable PET/CT images were successfully acquired at prespecified time points, as independently assessed by a senior nuclear medicine physician. Images were considered evaluable if they met diagnostic quality criteria.; Quality Control Standards for the Radiotracer Radiochemical purity ≥95% (determined by iTLC); Sterility (tested by the direct inoculation method according to pharmacopoeial standards); Bacterial endotoxins ≤15 EU/mL (as determined by photometry).; Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema. Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder. Safety and feasibility were evaluated by no adverse events after comprehensive indicators.	1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Uptake Value (SUV)	Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background ratio (SUVR) of [68Ga]Ga-THP-PDL1-3 in target lesions were observed. SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue.	Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): May 31, 2026
• Study Completion (Actual): September 24, 2026

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2026
• Last Update Submitted That Met QC Criteria: September 24, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Carbohydrates; Deoxyglucose; Deoxy Sugars; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2022KT74-ZY01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

In accordance with the ICMJE data-sharing guidelines and Chinese data-privacy laws, raw clinical and imaging data were not publicly available to prevent compromise of patient privacy. However, the corresponding author will share deidentified patient-level data, imaging parameters (SUV values), and study protocol details if reasonably requested by the requestor.

IPD Sharing Time Frame

Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.

IPD Sharing Access Criteria

Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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