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PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors

Not Applicable
Recruiting
Conditions
Solid Tumor
Interventions
Registration Number
NCT06383598
Lead Sponsor
Hua Zhu
Brief Summary

The objective of the study is to constrcut a noninvasive approach 68Ga-Nb-1 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.

Detailed Description

Analysis plan: 1. recruit 3 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria
  1. Aged >18 years old; ECOG 0 or 1;
  2. Patients with solid tumors;
  3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
  4. life expectancy >=12 weeks.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
68Ga-Nb-118F-FDGAll study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-Nb-1 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.
Primary Outcome Measures
NameTimeMethod
Standardized uptake value(SUV)2 years

The uptake of the tracer (68Ga-Nb-1) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Beijing Cancer Hospital

🇨🇳

Beijing, Beijing, China

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