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PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor

Primary Purpose

Lung Cancer, Melanoma, PD-L1

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-THP-APN09
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-75, male and female, with ECOG score of 0 or 1;
  2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);
  3. The expected survival was more than 26 weeks;
  4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;
  5. According to RECIST1.1, there was at least one measurable target lesion;
  6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
  7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria:

  1. The function of liver and kidney was seriously abnormal;
  2. Preparation for pregnant, pregnant and lactating women;
  3. Inability to lie flat for half an hour;
  4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.

Sites / Locations

  • Beijing cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging cohort

Arm Description

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-THP-APN09 PET/CT scans.

Outcomes

Primary Outcome Measures

MPR
In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.

Secondary Outcome Measures

PFS
progression free survival

Full Information

First Posted
December 8, 2021
Last Updated
March 27, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05156515
Brief Title
PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor
Official Title
PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of this study is to construct a noninvasive approach using 68Ga-THP-APN09 PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Melanoma, PD-L1, PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging cohort
Arm Type
Experimental
Arm Description
All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-THP-APN09 PET/CT scans.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-THP-APN09
Intervention Description
APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan.
Primary Outcome Measure Information:
Title
MPR
Description
In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
Time Frame
After 2-4 cycles of immunotherapy (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
PFS
Description
progression free survival
Time Frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-75, male and female, with ECOG score of 0 or 1; Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months); The expected survival was more than 26 weeks; Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT; According to RECIST1.1, there was at least one measurable target lesion; Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; Understand and sign informed consent voluntarily with good compliance. Exclusion Criteria: The function of liver and kidney was seriously abnormal; Preparation for pregnant, pregnant and lactating women; Inability to lie flat for half an hour; Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhu
Phone
010-88196495
Email
zhuhuabch@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Zhu
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Zhu
Phone
010-88196495
Email
zhuhuabch@pku.edu.cn

12. IPD Sharing Statement

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PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor

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