Bladder (Urothelial, Transitional Cell) Cancer Metastatic or UnresectablePhase 2FAUNUSNCT06880757
177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.
A Phase 2 study testing Radionuclide treatment with Lu-177 FAPI in people with Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable, run by Ankara University.
Trial summary
Ga-68-FAPI has recently been proven to be superior to F-18-FDG in various cancers. These results have also raised hope in using FAP radiopharmaceuticals with theranostic approach. Lu-177 bound FAPI molecules have been started to be used in some cancers in clinical trials following its efficacy proven by case reports. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
- What is being tested?
- Radionuclide treatment with Lu-177 FAPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated.
- Patients aged >18y, male or female gender
- Patients who are willing to cooperate with the study protocol, including the therapy regimen, posttherapy imaging and follow up visits
- Patients who read and signed the written informed consent form.
- A positive Ga-68-FAPI scan result (at least 50% of the lesions with an SUVmax >1.5 times liver SUVmax )
- Blood tests (Platelets>120.000/mm3, Neutrophils>1500cell/mm3, Hb>8g/dL
Show all 11Show fewer
- Liver function tests: (ALT and AST<2.5Xupper limit of normal, Bilirubin<2mg/dL, Total bilirubin<1.5X upper limit of normal
- PT, aPTT and INR in normal range
- Normal GFR, serum Cr levels
- ECOG 0-1
- Life expectancy longer than 6 months
Who cannot join
- Low Ga-68-FAPI uptake
- Not willing to sign informed consent form
- ECOG >1
- Hematological tests and renal function tests are not eligible
- Disseminated bone marrow metastasis
- Central nervous system metastasis or existence of any lesion with risk of compression
Show all 9Show fewer
- Co-existing secondary malignancies
- Previous radioligand therapies
- Being received anticancer therapies in 4 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Ga-68-FAPI has recently been proven to be superior to F-18-FDG in various cancers. These results have also raised hope in using FAP radiopharmaceuticals with theranostic approach. Lu-177 bound FAPI molecules have been started to be used in some cancers in clinical trials following its efficacy proven by case reports. Similarly,as a pilot study, this project aims to investigate safety and efficacy of Lu-177- FAP-2286 in metastatic urothelial carcinomas of bladder.
A total of 10 histopathologically proven urothelial bladder cancer patients >18y of age will be included in the study. After taking informed consent, all patients will undergo both 18F-FDG PET/CT and 68Ga-FAPI PET/CT for restaging before initiation of Lu-177-FAP-2286. Patients who show progression despite advanced therapies and high Ga-68 FAPI uptake will be enrolled. Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated. Radiopharmaceutical will be administered 150mCi fixed dose, 3 cycles, 8 weeks interval. Posttherapy whole body SPECT/CT imaging will be obtained 4.,24.,96,120Hours of treatment for dosimetric calculations. All patients will be monitored for safety issues and possible long term side effects. Hematological tests, renal and liver function tests will be performed every 2 weeks, radiological imaging for tumor response assessment will be performed every 6 weeks. Symptoms will be taken under consideration for symptomatic response QoL questioner. In case of objective progression, therapy will be stopped. Otherwise, will be completed to 4 cycles.
Administration of Lu-177 FAPİ treatment will be performed by 1st partner from Turkey. Posttreatment SPECT/CT images will be obtained and collected for dosimetric calculations. Heatly organ doses and tumor doses will be calculated bt 2nd partner form Italy in collaboration with 1st partner. In consideration of the advances in radionuclide treatments to achieve objective response within safety margins to healthy organs, dosimetric approaches are mandatory. As a novel treatment dosimetric data for Lu-177 FAPİ treatment is limited. Despite to being a reference center for radionuclide treatments 1st partner has no experience on dosimetric calculations for systemic radionuclide treatments. As an experienced center for dosimetric studies, 2nd partner will be a milestone for analysis of dose response and toxicity analyses for this pilot study of novel treatment.
Read the detailed description
Bladder cancer has a variable incidence worldwide, changing with environmental factors. Urothelial carcinoma the the most common histopathological subtype. Early-stage bladder cancer has a favoruable prognosis, despite high survival rates (5years survival rate 40-70%). Advanced stage, however, has a very poor prognosis, with high metastatic rate. In these patients, several agents have been tried to improve outcomes. Radionuclide therapies gained importance in multiple cancer types, including prostate carcinoma, with recent reports proving its efficacy in especially metastatic, inoperable, advanced stage disease (1-4). In advanced stage bladder cancer, the role of radionuclide treatments has not been investigated yet. But in case a metabolic pathway can be viualised by a diagnostic radiopharmaceutical, then radiolabeled lesions can also be cured by the theranostic pair. Although F-18-FDG is a very good agent for detecting metastatic disease in bladder cancer, it cannot be used for theranostic purposes. Other routes are thus investigated for this aim.
Fibroblast activation protein (FAP) is highly expressed in the stroma of several tumor entities. Especially breast, colon, and pancreatic carcinomas are characterized by a strong desmoplastic reaction, which means that 90% of the gross tumor mass can consist of stromal but not tumor cells. Fibroblasts are present ubiquitously in the whole body and show very low or no FAP expression. In contrast, cancer-associated fibroblasts are specifically characterized by the expression of FAP (5).
Thus, cancer-associated fibroblasts differ from normal fibroblasts by providing FAP as a target with a relatively high tumor-specific expression, and FAP inhibitors (FAPIs) have already been developed as cancer drugs (6,7). Based on a quinoline-based FAP-specific inhibitor (6), a new class of radiopharmaceuticals was designed and found preclinically highly promising as molecular targeting imaging probes, and it is hoped that they also will be therapeutically useful (8,9).
First-in-human cases demonstrated high-contrast tumor imaging in various cancers, including bladder cancer (8-11). Thus, it has also been recognized as a promising target for therapy. To date, there are no studies available investigating FAPI targeted radionuclide therapy in bladder cancer.
The major aim of this study is investigating the safety and efficacy of Lu-177 FAP-2286 in advanced stage urothelial bladder cancer. The study is planned as a pilot study in a relatively small group of patients.
For non-standardised therapies, radionuclide therapies are adviced to be given with a dosimetric approach. In personalized therapies, dosimetry allows improved safety and efficacy, easier monitorisation of therapy, accurate measurement of radiation doses and thus minimizing adverse event rates while maximizing the therapeutic benefit in the targeted areas. So the secondary aim of this study is to make a dosimetric study, including the investigation of physiological distribution and pharmacokinetics-pharmacodynamics of this novel radiopharmaceutical.
Proving safety and efficacy in this pilot study will lead to open a window for its use in further clinical studies conducted in larger patient populations. Supported by further studies, a new therapeutic option will hopefully be developed for incurable bladder cancer.
- Being tested
- Radionuclide treatment with Lu-177 FAPI
- Keywords
- Bladder Cancer, Radionuclide treatment, Dosimetry
- Medical subject headings
- Neoplasm Metastasis, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radionuclide treatment with Lu-177 FAPIOther
Systemic radionuclide treatment with Lu-177 FAPI
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients with metastatic bladder cancer who will received Lu-177 FAPI treatment Receives: Other: Radionuclide treatment with Lu-177 FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Lu-177-FAP-2286
Efficacy of Lu-177-FAP-2286 based on objective response rate according to RECIST.
Measured: 1 to 30 months
Dosimetry of Lu-177-Fap-2286
Radiation dosimetry of Lu-177-FAP-2286 to tumoral lesions and healthy organs measured by absorbed dose estimates (Gy)
Measured: 6 to 30 months
Safety of Lu-177-FAP-2286
Determination of short and long term adverse events
Measured: 6 to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) Cancer Metastatic or UnresectableStudies of the same condition, open and under way.
- More trials run by Ankara 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Soydal, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880757
- Sponsor's protocol ID
- 2024-KAEK-05
- Acronym
- FAUNUS
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.
- ClinicalTrials.gov ID
- NCT06880757
- Acronym / sponsor ID
- FAUNUS / 2024-KAEK-05
- Keywords
- Bladder Cancer, Radionuclide treatment, Dosimetry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 18 Mar 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.
Ga-68-FAPI has recently been proven to be superior to F-18-FDG in various cancers. These results have also raised hope in using FAP radiopharmaceuticals with theranostic approach. Lu-177 bound FAPI molecules have been started to be used in some cancers in clinical trials following its efficacy proven by case reports. Similarly,as a pilot study, this project aims to investigate safety and efficacy of Lu-177- FAP-2286 in metastatic urothelial carcinomas of bladder.
A total of 10 histopathologically proven urothelial bladder cancer patients >18y of age will be included in the study. After taking informed consent, all patients will undergo both 18F-FDG PET/CT and 68Ga-FAPI PET/CT for restaging before initiation of Lu-177-FAP-2286. Patients who show progression despite advanced therapies and high Ga-68 FAPI uptake will be enrolled. Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated. Radiopharmaceutical will be administered 150mCi fixed dose, 3 cycles, 8 weeks interval. Posttherapy whole body SPECT/CT imaging will be obtained 4.,24.,96,120Hours of treatment for dosimetric calculations. All patients will be monitored for safety issues and possible long term side effects. Hematological tests, renal and liver function tests will be performed every 2 weeks, radiological imaging for tumor response assessment will be performed every 6 weeks. Symptoms will be taken under consideration for symptomatic response QoL questioner. In case of objective progression, therapy will be stopped. Otherwise, will be completed to 4 cycles.
Administration of Lu-177 FAPİ treatment will be performed by 1st partner from Turkey. Posttreatment SPECT/CT images will be obtained and collected for dosimetric calculations. Heatly organ doses and tumor doses will be calculated bt 2nd partner form Italy in collaboration with 1st partner. In consideration of the advances in radionuclide treatments to achieve objective response within safety margins to healthy organs, dosimetric approaches are mandatory. As a novel treatment dosimetric data for Lu-177 FAPİ treatment is limited. Despite to being a reference center for radionuclide treatments 1st partner has no experience on dosimetric calculations for systemic radionuclide treatments. As an experienced center for dosimetric studies, 2nd partner will be a milestone for analysis of dose response and toxicity analyses for this pilot study of novel treatment.
Detailed description
Bladder cancer has a variable incidence worldwide, changing with environmental factors. Urothelial carcinoma the the most common histopathological subtype. Early-stage bladder cancer has a favoruable prognosis, despite high survival rates (5years survival rate 40-70%). Advanced stage, however, has a very poor prognosis, with high metastatic rate. In these patients, several agents have been tried to improve outcomes. Radionuclide therapies gained importance in multiple cancer types, including prostate carcinoma, with recent reports proving its efficacy in especially metastatic, inoperable, advanced stage disease (1-4). In advanced stage bladder cancer, the role of radionuclide treatments has not been investigated yet. But in case a metabolic pathway can be viualised by a diagnostic radiopharmaceutical, then radiolabeled lesions can also be cured by the theranostic pair. Although F-18-FDG is a very good agent for detecting metastatic disease in bladder cancer, it cannot be used for theranostic purposes. Other routes are thus investigated for this aim.
Fibroblast activation protein (FAP) is highly expressed in the stroma of several tumor entities. Especially breast, colon, and pancreatic carcinomas are characterized by a strong desmoplastic reaction, which means that 90% of the gross tumor mass can consist of stromal but not tumor cells. Fibroblasts are present ubiquitously in the whole body and show very low or no FAP expression. In contrast, cancer-associated fibroblasts are specifically characterized by the expression of FAP (5).
Thus, cancer-associated fibroblasts differ from normal fibroblasts by providing FAP as a target with a relatively high tumor-specific expression, and FAP inhibitors (FAPIs) have already been developed as cancer drugs (6,7). Based on a quinoline-based FAP-specific inhibitor (6), a new class of radiopharmaceuticals was designed and found preclinically highly promising as molecular targeting imaging probes, and it is hoped that they also will be therapeutically useful (8,9).
First-in-human cases demonstrated high-contrast tumor imaging in various cancers, including bladder cancer (8-11). Thus, it has also been recognized as a promising target for therapy. To date, there are no studies available investigating FAPI targeted radionuclide therapy in bladder cancer.
The major aim of this study is investigating the safety and efficacy of Lu-177 FAP-2286 in advanced stage urothelial bladder cancer. The study is planned as a pilot study in a relatively small group of patients.
For non-standardised therapies, radionuclide therapies are adviced to be given with a dosimetric approach. In personalized therapies, dosimetry allows improved safety and efficacy, easier monitorisation of therapy, accurate measurement of radiation doses and thus minimizing adverse event rates while maximizing the therapeutic benefit in the targeted areas. So the secondary aim of this study is to make a dosimetric study, including the investigation of physiological distribution and pharmacokinetics-pharmacodynamics of this novel radiopharmaceutical.
Proving safety and efficacy in this pilot study will lead to open a window for its use in further clinical studies conducted in larger patient populations. Supported by further studies, a new therapeutic option will hopefully be developed for incurable bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Other: Radionuclide treatment with Lu-177 FAPIPatients with metastatic bladder cancer who will received Lu-177 FAPI treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated.
Key exclusion criteria (9 listed)
- Low Ga-68-FAPI uptake
- Not willing to sign informed consent form
- ECOG >1
- Hematological tests and renal function tests are not eligible
- Disseminated bone marrow metastasis
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 treatment with Lu-177 FAPISystemic radionuclide treatment with Lu-177 FAPI | Other | Treatment arm |
Primary outcome
Efficacy of Lu-177-FAP-2286
Time frame: 1 to 30 months
Efficacy of Lu-177-FAP-2286 based on objective response rate according to RECIST.
Dosimetry of Lu-177-Fap-2286
Time frame: 6 to 30 months
Radiation dosimetry of Lu-177-FAP-2286 to tumoral lesions and healthy organs measured by absorbed dose estimates (Gy)
Safety of Lu-177-FAP-2286
Time frame: 6 to 36 months
Determination of short and long term adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radionuclide treatment with Lu-177 FAPI in people with Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable, run by Ankara University.
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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cigdem Soydal, Prof (+903125956732, csoydal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Lu-177-FAP-2286 (time frame: 1 to 30 months). The study lists 3 primary outcomes in all. 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 18 Mar 2025.