Malignant Solid TumorsPhase 1NCT05930457
Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
A Phase 1 study testing 2.5-3.5mCi 64Cu-FAPI-XT117, 3.5-4.5mCi 64Cu-FAPI-XT117 and 4.5-5.5mCi 64Cu-FAPI-XT117 in people with Malignant Solid Tumors, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This is the study of 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?
- 2.5-3.5mCi 64Cu-FAPI-XT117, 3.5-4.5mCi 64Cu-FAPI-XT117 and 4.5-5.5mCi 64Cu-FAPI-XT117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2023to 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 Affiliated Hospital of Guangzhou Medical University
Guangzhou
About this study
This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
- Conditions
- Malignant Solid Tumors
- Being tested
- 2.5-3.5mCi 64Cu-FAPI-XT117, 3.5-4.5mCi 64Cu-FAPI-XT117, 4.5-5.5mCi 64Cu-FAPI-XT117
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5-3.5mCi 64Cu-FAPI-XT117Drug
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 2.5-3.5mCi 64Cu-FAPI-XT117 injection.
3.5-4.5mCi 64Cu-FAPI-XT117Drug
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 3.5-4.5mCi 64Cu-FAPI-XT117 injection.
4.5-5.5mCi 64Cu-FAPI-XT117Drug
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 4.5-5.5mCi 64Cu-FAPI-XT117 injection.
| Study group | Role | What they receive |
|---|---|---|
| 64Cu-FAPI-XT117 PET/CT | Experimental | Not described Receives: Drug: 2.5-3.5mCi 64Cu-FAPI-XT117; Drug: 3.5-4.5mCi 64Cu-FAPI-XT117; Drug: 4.5-5.5mCi 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 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 64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 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 posted5 Jul 2023
- Study start26 Jul 2023
- Primary completion31 Oct 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 The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sinotau Pharmaceutical Group
- Responsible party
- Principal investigator, Xinlu Wang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930457
- Sponsor's protocol ID
- XT-XTR016-1-02
- Status last verified
- Dec 2023
- First submitted
- 26 Jun 2023
- Last updated
- 26 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05930457
- Acronym / sponsor ID
- XT-XTR016-1-02
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Sinotau Pharmaceutical Group
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 5 Jul 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 study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 64Cu-FAPI-XT117 PET/CT | Experimental | Drug: 2.5-3.5mCi 64Cu-FAPI-XT117, Drug: 3.5-4.5mCi 64Cu-FAPI-XT117, Drug: 4.5-5.5mCi 64Cu-FAPI-XT117 |
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 |
|---|---|---|
| 2.5-3.5mCi 64Cu-FAPI-XT11764Cu-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 2.5-3.5mCi 64Cu-FAPI-XT117 injection. | Drug | 64Cu-FAPI-XT117 PET/CT |
| 3.5-4.5mCi 64Cu-FAPI-XT11764Cu-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 3.5-4.5mCi 64Cu-FAPI-XT117 injection. | Drug | 64Cu-FAPI-XT117 PET/CT |
| 4.5-5.5mCi 64Cu-FAPI-XT11764Cu-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 4.5-5.5mCi 64Cu-FAPI-XT117 injection. | Drug | 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 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 26 Dec 2023.
Related trials for Malignant Solid Tumors
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 2.5-3.5mCi 64Cu-FAPI-XT117, 3.5-4.5mCi 64Cu-FAPI-XT117 and 4.5-5.5mCi 64Cu-FAPI-XT117 in people with Malignant Solid Tumors, run by The First Affiliated Hospital of Guangzhou Medical University 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 26 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 26 Dec 2023.