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

Hua Zhu

Status: Enrolling

Conditions: Solid Tumor

Treatments: Drug: 18F-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT06383598

2022KT74-ZY01

Details and patient eligibility

About

The objective of the study is to constrcut a noninvasive approach 68Ga-THP-PD-L1-3 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged >18 years old; ECOG 0 or 1;
2. Patients with solid tumorsin or suspected tumor lesions;
3. life expectancy >=12 weeks.

Exclusion criteria

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
5. Suffering from claustrophobia or other mental diseases;
6. Any other situation that researchers think it is not suitable to participate in the experiment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

68Ga-THP-PD-L1-3

Experimental group

Description:

All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-THP-PD-L1-3 PET/CT scans (At the investigator's discretion, a total of no more than 0.5 mg of non-radiolabeled precursor may be considered for injection. To reduce liver and bone marrow uptake). After resting for 40 minutes or 1 hour, participants underwent United Imaging Healthcare total-body PET/CT for whole body scans or a Siemens Biograph m-CT flow PET/CT from the top of the head to the upper third of the thighs.

Treatment:

Drug: 18F-FDG