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NCT Number: NCT06383598

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

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Key information

Conditions

Solid Tumor

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Hua Zhu

CONTACT

[email protected]

+861088196495

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

18F-FDG

Drug

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

[68Ga]Ga-THP-PDL1-3

Drug

[68Ga]Ga-THP-PDL1-3 is an investigational tracer, and all participants will undergo [68Ga]Ga-THP-PDL1-3 scanning.

Primary outcomes

  1. Safety and Feasibility

    Time frame: 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.

    • 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.

Secondary outcomes

  1. Standardized Uptake Value (SUV)

    Time frame: Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zhu

CONTACT

[email protected]

010-88196495

Sponsors and collaborators

Lead sponsor

Hua Zhu

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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