Metastatic Solid Tumors (Any Localization)Early Phase 1NCT07299253
Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06
A Early Phase 1 study testing radionuclide therapy with [177Lu]Lu--TEFAPI-06 in people with Metastatic Solid Tumors (Any Localization), run by Lanzhou University Second Hospital at 1 site in China.
Trial summary
This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of [177Lu]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors (Any Localization)
- What is being tested?
- radionuclide therapy with [177Lu]Lu--TEFAPI-06
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2023to 16 Aug 2025
- Phase
- Early 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
- Age > 18 years
- Histologically confirmed advanced metastatic solid tumors refractory or intolerant to standard therapies
- ECOG performance status 0-2
- Life expectancy > 3 months
- At least one FAP-avid lesion confirmed by baseline [18F]-FAPI PET/CT
- Adequate organ and bone marrow function prior to the first dose
Who cannot join
- Chemotherapy, radiotherapy, or targeted therapy within 4 weeks
- Severe hepatic or renal dysfunction
- Uncontrolled active infection or severe comorbidities
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, 730000
About this study
Official title: Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06: A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of [177Lu]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.
Read the detailed description
This study represents a comprehensive "bench-to-bedside" translational investigation, providing the first systematic report on the safety profile of [177Lu]Lu-TEFAPI-06-a novel albumin-binding fibroblast activation protein inhibitor (FAPI) radiopharmaceutical-and its successful transition into a FIH. The investigators preliminarily evaluated its safety, dosimetry, and therapeutic response in patients with ibroblast activation protein (FAP)-overexpressing metastatic solid tumors.
- Being tested
- radionuclide therapy with [177Lu]Lu--TEFAPI-06
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radionuclide therapy with [177Lu]Lu--TEFAPI-06Drug
A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced metastatic solid tumors | Experimental | Not described Receives: Drug: radionuclide therapy with [177Lu]Lu--TEFAPI-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Safety and tolerability will be assessed by recording the frequency, duration, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). The assessment includes clinically significant changes in vital signs (blood pressure, heart rate, respiratory rate, temperature), physical examination findings, 12-lead Electrocardiogram (ECG) parameters, and clinical laboratory tests (including Complete Blood Count [CBC], Urinalysis, Liver Function Tests [LFTs], and Renal Function Tests). Severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Measured: From Baseline up to 30 days after the last dose of study intervention (approximately 4 weeks)
Secondary outcomes (2)
Change from Baseline in [18F]-FAPI PET/CT Parameters in Target Lesions
[18F]-FAPI PET/CT images will be acquired to evaluate the expression of FAP within the tumor stroma. The efficacy assessment will be based on the quantitative analysis of Standardized Uptake Values (SUVmax and SUVmean) and Tumor-to-Background Ratios (TBR) of the target lesions. Changes in tracer uptake between the baseline scan and the follow-up scan will be calculated.
Measured: Baseline (Day 0) and 1 month post-treatment.
Change from Baseline in Tumor-Specific Serum Marker Levels
Peripheral blood samples will be collected to measure the serum concentration of tumor-specific biomarkers relevant to the indication (e.g., CEA, CA19-9, PSA, or other applicable markers). The change in concentration levels will be assessed to evaluate biochemical response.
Measured: Baseline (Day 0) and 1 month post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start16 Aug 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid Tumors (Any Localization)Studies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangyan Liu, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299253
- Sponsor's protocol ID
- 2023A-371
- Status last verified
- Oct 2025
- First submitted
- 26 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06: A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
- ClinicalTrials.gov ID
- NCT07299253
- Acronym / sponsor ID
- 2023A-371
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 23 Dec 2025 (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 study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of [177Lu]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.
Detailed description
This study represents a comprehensive "bench-to-bedside" translational investigation, providing the first systematic report on the safety profile of [177Lu]Lu-TEFAPI-06-a novel albumin-binding fibroblast activation protein inhibitor (FAPI) radiopharmaceutical-and its successful transition into a FIH. The investigators preliminarily evaluated its safety, dosimetry, and therapeutic response in patients with ibroblast activation protein (FAP)-overexpressing metastatic solid tumors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced metastatic solid tumors | Experimental | Drug: radionuclide therapy with [177Lu]Lu--TEFAPI-06 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Histologically confirmed advanced metastatic solid tumors refractory or intolerant to standard therapies
- ECOG performance status 0-2
- Life expectancy > 3 months
- At least one FAP-avid lesion confirmed by baseline [18F]-FAPI PET/CT
Key exclusion criteria (3 listed)
- Chemotherapy, radiotherapy, or targeted therapy within 4 weeks
- Severe hepatic or renal dysfunction
- Uncontrolled active infection or severe comorbidities
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 |
|---|---|---|
| radionuclide therapy with [177Lu]Lu--TEFAPI-06A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics | Drug | Patients with advanced metastatic solid tumors |
Primary outcome
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Time frame: From Baseline up to 30 days after the last dose of study intervention (approximately 4 weeks)
Safety and tolerability will be assessed by recording the frequency, duration, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). The assessment includes clinically significant changes in vital signs (blood pressure, heart rate, respiratory rate, temperature), physical examination findings, 12-lead Electrocardiogram (ECG) parameters, and clinical laboratory tests (including Complete Blood Count [CBC], Urinalysis, Liver Function Tests [LFTs], and Renal Function Tests). Severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
2 secondary outcomes
Change from Baseline in [18F]-FAPI PET/CT Parameters in Target Lesions
Time frame: Baseline (Day 0) and 1 month post-treatment.
Change from Baseline in Tumor-Specific Serum Marker Levels
Time frame: Baseline (Day 0) and 1 month post-treatment.
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 23 Dec 2025.
- Individual participant dataSharing planned: No
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 Early Phase 1 study testing radionuclide therapy with [177Lu]Lu--TEFAPI-06 in people with Metastatic Solid Tumors (Any Localization), run by Lanzhou University Second 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 6 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 23 Dec 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 (time frame: From Baseline up to 30 days after the last dose of study intervention (approximately 4 weeks)). 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 23 Dec 2025.