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

Launched by ANKARA UNIVERSITY · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Lu-177-FAP-2286 for patients with advanced bladder cancer that cannot be treated with standard therapies. The study aims to see how safe and effective this treatment is, especially in patients whose cancer has not responded to other treatments. To participate, patients need to be over 18 years old and have a confirmed diagnosis of advanced bladder cancer that has not improved despite previous therapies. They must also have specific test results showing that their cancer is likely to respond to this new treatment.

If eligible, participants will receive three cycles of Lu-177-FAP-2286, administered every eight weeks, and will undergo regular health checks to monitor their progress and any side effects. This includes blood tests and imaging scans to assess how well the treatment is working. Patients will also be closely monitored for any potential long-term side effects. It's important to note that the trial is not yet recruiting participants, and those interested should be aware of the eligibility criteria before considering joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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