Refractory Solid TumorPhase 2NCT05963386
Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors
A Phase 2 study testing 177Lu-DOTA-EB-FAPI radionuclide therapy in people with Refractory Solid Tumor, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Refractory Solid Tumor
- What is being tested?
- 177Lu-DOTA-EB-FAPI radionuclide therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2022to 5 Oct 2024
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 and older.
- Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
- Progressive disease after multiple-lines treatment.
- Completion of entry into 68Ga-FAPI-46 study and completion of scan. The tumor lesions showing increased radiotracer uptake on 68Ga-FAPI-46 PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions).
- Able to remain motionless for up to 30-60 minutes per scan.
Who cannot join
- Serum creatinine level >150 μmol/L.
- Hemoglobin level <8.0 g/dL; white-cell count < 2.0×109/L; platelet count < 50×109/L; total bilirubin level >3 times the upper limit of the normal range and serum albumin level <2.0 g/dL.
- Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- Participants with severe allergy, or hypersensitivity to radiographic contrast material.
- Participants with claustrophobia.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
About this study
Official title: An Open-Label, Non-Randomized, Single-Center, Investigator-initiated Phase II Trial to Determine the Efficacy and Safety of 177Lu-DOTA-EB-FAPI in Patients With Various End-stage Solid Tumors
Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to investigate the efficacy and safety of 177Lu-DOTA-EB-FAPI in patients with various solid tumors who had failed standard therapies.
Read the detailed description
This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.
- Conditions
- Refractory Solid Tumor
- Being tested
- 177Lu-DOTA-EB-FAPI radionuclide therapy
- Keywords
- Refractory solid tumor, Radioligand therapy, 177Lu-DOTA-EB-FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTA-EB-FAPI radionuclide therapyDrug
radionuclide therapy using 177Lu-DOTA-EB-FAPI 90 mCi (3.3 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-DOTA-EB-FAPI | Experimental | 177Lu-DOTA-EB-FAPI A maximum of 4 cycles of 90 mCi (3.3 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks Receives: Drug: 177Lu-DOTA-EB-FAPI radionuclide therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological response (according to RECIST criteria)
RECIST objective response after completion of radioligand therapy, which was defined by response category between baseline and restaging after RLT. Disease control after RLT was defined as either complete response (CR), partial response (PR), or stable disease (SD). Disease control rate (DCR) was reported as the proportion of patients with disease control after RLT.
Measured: 6 weeks, 12 weeks, 18 weeks, or up to 6 months
Secondary outcomes (2)
Progression-free survival (PFS) and overall survival (OS)
PFS was recorded from start of RLT until RECIST progression, death, or last follow-up. OS was recorded from start of RLT until death or last follow-up conducted for all patients at the end of August 2024.
Measured: disease progression, death or last follow-up conducted for all patients at the end of August 2024.
Dosimetry
Dosimetry, measured as the absorbed dose in tumors (Gy/GBq), was estimated in the first treatment cycle for each patient.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start22 Feb 2022
- Primary completion15 Sep 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Solid TumorStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963386
- Sponsor's protocol ID
- XMFHIIT-2023KY037
- Status last verified
- Mar 2025
- First submitted
- 17 Jul 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Single-Center, Investigator-initiated Phase II Trial to Determine the Efficacy and Safety of 177Lu-DOTA-EB-FAPI in Patients With Various End-stage Solid Tumors
- ClinicalTrials.gov ID
- NCT05963386
- Acronym / sponsor ID
- XMFHIIT-2023KY037
- Conditions
- Refractory Solid Tumor
- Keywords
- Refractory solid tumor, Radioligand therapy, 177Lu-DOTA-EB-FAPI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 27 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.
Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to investigate the efficacy and safety of 177Lu-DOTA-EB-FAPI in patients with various solid tumors who had failed standard therapies.
Detailed description
This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-DOTA-EB-FAPI | Experimental | Drug: 177Lu-DOTA-EB-FAPI radionuclide therapy177Lu-DOTA-EB-FAPI A maximum of 4 cycles of 90 mCi (3.3 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 and older.
- Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
- Progressive disease after multiple-lines treatment.
- Completion of entry into 68Ga-FAPI-46 study and completion of scan. The tumor lesions showing increased radiotracer uptake on 68Ga-FAPI-46 PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions).
Key exclusion criteria (6 listed)
- Serum creatinine level >150 μmol/L.
- Hemoglobin level <8.0 g/dL; white-cell count < 2.0×109/L; platelet count < 50×109/L; total bilirubin level >3 times the upper limit of the normal range and serum albumin level <2.0 g/dL.
- Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- Participants with severe allergy, or hypersensitivity to radiographic contrast material.
- Participants with claustrophobia.
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 |
|---|---|---|
| 177Lu-DOTA-EB-FAPI radionuclide therapyradionuclide therapy using 177Lu-DOTA-EB-FAPI 90 mCi (3.3 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered. | Drug | 177Lu-DOTA-EB-FAPI |
Primary outcome
Radiological response (according to RECIST criteria)
Time frame: 6 weeks, 12 weeks, 18 weeks, or up to 6 months
RECIST objective response after completion of radioligand therapy, which was defined by response category between baseline and restaging after RLT. Disease control after RLT was defined as either complete response (CR), partial response (PR), or stable disease (SD). Disease control rate (DCR) was reported as the proportion of patients with disease control after RLT.
2 secondary outcomes
Progression-free survival (PFS) and overall survival (OS)
Time frame: disease progression, death or last follow-up conducted for all patients at the end of August 2024.
Dosimetry
Time frame: 6 weeks
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 28 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 2 study testing 177Lu-DOTA-EB-FAPI radionuclide therapy in people with Refractory Solid Tumor, run by The First Affiliated Hospital of Xiamen 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 6 inclusion and 6 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 28 Mar 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Radiological response (according to RECIST criteria) (time frame: 6 weeks, 12 weeks, 18 weeks, or up to 6 months). 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 28 Mar 2025.