177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.

NCT06880757 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-KAEK-05
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable

Keywords

Bladder Cancer; Radionuclide treatment; Dosimetry

Outcome Measures

Primary Outcomes (3)

• Efficacy of Lu-177-FAP-2286

  Efficacy of Lu-177-FAP-2286 based on objective response rate according to RECIST.

  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)

  6 to 30 months

• Safety of Lu-177-FAP-2286

  Determination of short and long term adverse events

  6 to 36 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients with metastatic bladder cancer who will received Lu-177 FAPI treatment

Other: Radionuclide treatment with Lu-177 FAPI

Interventions

Radionuclide treatment with Lu-177 FAPI OTHER

Systemic radionuclide treatment with Lu-177 FAPI

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Co-existing secondary malignancies
• Previous radioligand therapies
• Being received anticancer therapies in 4 weeks

Sponsors & Collaborators

• Ankara University: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator

MeSH Terms

Conditions

Neoplasm Metastasis; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Cigdem Soydal, Prof

CONTACT

+903125956732; csoydal@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Nuclear Medicine

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03