Malignant Solid TumorsPhase 1NCT05814835
First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
A Phase 1 study testing 2-4 mCi 68Ga/64Cu-FAPI-XT117, 4-6 mCi 68Ga/64Cu-FAPI-XT117 and 6-8 mCi 68Ga/64Cu-FAPI-XT117 in people with Malignant Solid Tumors, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumors
- What is being tested?
- 2-4 mCi 68Ga/64Cu-FAPI-XT117, 4-6 mCi 68Ga/64Cu-FAPI-XT117 and 6-8 mCi 68Ga/64Cu-FAPI-XT117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2022to 18 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. signed the informed consent
- 2. ≥18 years old
- 3. confirmed as malignant solid tumor by histopathology or clinical judgment
- 4. Patients will undergo 18F-FDG PET/CT examination
Who cannot join
- 1. Known allergy to components of the investigational drug or its analogues
- 2. suspected to have a certain disease or condition that is not suitable for the study drug
- 3. Known pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
the First Medical Center, Chinese PLA General Hospital
Beijing, 100023
About this study
Official title: First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant
This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
Read the detailed description
20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.
- Conditions
- Malignant Solid Tumors
- Being tested
- 2-4 mCi 68Ga/64Cu-FAPI-XT117, 4-6 mCi 68Ga/64Cu-FAPI-XT117, 6-8 mCi 68Ga/64Cu-FAPI-XT117
- Keywords
- 68Ga-FAPI 64Cu-FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-4 mCi 68Ga/64Cu-FAPI-XT117Drug
68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection.
4-6 mCi 68Ga/64Cu-FAPI-XT117Drug
68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection.
6-8 mCi 68Ga/64Cu-FAPI-XT117Drug
68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 6-8 mCi 68Ga/64Cu-FAPI-XT117 injection.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga/64Cu-FAPI-XT117 PET/CT | Experimental | Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT. Receives: Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117; Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117; Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluation of Adverse Events (AE) Using CTCAE
Measured: 7 days following injection
Secondary outcomes (2)
The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)
Measured: 2 months following injection
Change in 'treatment strategy questionnaire'
Referring physicians were asked to complete and return 2 questionnaires. The first assessed the existing treatment plan for the patient without the information from 68Ga/64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 68Ga/64Cu-FAPI-XT PET images.
Measured: 2 months following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start7 Dec 2022
- Primary completion30 Nov 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinotau Pharmaceutical Group
- Responsible party
- Principal investigator, Ruimin Wang, Chinese PLA General Hospital
- Investigators
- Ruimin Wang, Principal investigator, the First Medical Center, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814835
- Sponsor's protocol ID
- XT-XTR016-1-01
- Status last verified
- Dec 2023
- First submitted
- 3 Mar 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant
- ClinicalTrials.gov ID
- NCT05814835
- Acronym / sponsor ID
- XT-XTR016-1-01
- Conditions
- Malignant Solid Tumors
- Keywords
- 68Ga-FAPI 64Cu-FAPI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Sinotau Pharmaceutical Group
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
Detailed description
20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga/64Cu-FAPI-XT117 PET/CT | Experimental | Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117, Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117, Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. signed the informed consent
- 2. ≥18 years old
- 3. confirmed as malignant solid tumor by histopathology or clinical judgment
- 4. Patients will undergo 18F-FDG PET/CT examination
Key exclusion criteria (3 listed)
- 1. Known allergy to components of the investigational drug or its analogues
- 2. suspected to have a certain disease or condition that is not suitable for the study drug
- 3. Known pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-4 mCi 68Ga/64Cu-FAPI-XT11768Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection. | Drug | 68Ga/64Cu-FAPI-XT117 PET/CT |
| 4-6 mCi 68Ga/64Cu-FAPI-XT11768Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection. | Drug | 68Ga/64Cu-FAPI-XT117 PET/CT |
| 6-8 mCi 68Ga/64Cu-FAPI-XT11768Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 6-8 mCi 68Ga/64Cu-FAPI-XT117 injection. | Drug | 68Ga/64Cu-FAPI-XT117 PET/CT |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 7 days following injection
Evaluation of Adverse Events (AE) Using CTCAE
2 secondary outcomes
The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
Time frame: 2 months following injection
Change in 'treatment strategy questionnaire'
Time frame: 2 months following injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruimin Wang principal investigator
the First Medical Center, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2-4 mCi 68Ga/64Cu-FAPI-XT117, 4-6 mCi 68Ga/64Cu-FAPI-XT117 and 6-8 mCi 68Ga/64Cu-FAPI-XT117 in people with Malignant Solid Tumors, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 7 days following injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.