XCancer

Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma

Description:

This study is an open label, Phase I study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC. This trial is divided in 2 parts: * The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Eligible patients will be treated with escalating activity of 161Tb-PSMA. * The extension part aims to collect preliminary clinical activity data of the proposed treatment.

Sponsor:

Centre Leon Berard

Phase:

Phase 1

Contacts:

Anne-Laure GIRAUDET, MD (CONTACT)

anne-laure.giraudet@lyon.unicancer.fr

04 78 78 20 21

Government Study Link:

NCT07828249 - Click here to see study on

ClinicalTrials.gov

PSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

PSMA-1

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Inclusion
  • Platelet count ≥ 100 x 109/L
  • For patient with both extra-hepatic and liver metastasis: ≥ 50% of positive extrahepatic metastatic lesions and ≥ 80 % of positive supracentimetric liver metastatic lesions.
  • I7. Adequate organ function according to laboratory values defined below:Haematological function :
  • For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic lesions
Exclusion
  • Patients previously treated with any radiopharmaceutical.
  • Patients with clinically significant hematuria, hematemesis or hemoptysis exceeding 0.5 teaspoon (2.5mL) of red blood, as well as those with a history of coagulopathy or other significant bleeding (e.g., pulmonary hemorrhage) within the 3 months prior to the initiation of the study treatment. Patients receiving anticoagulation medication will be eligible only if the dosage and route of administration have remained stable for at least 2 weeks prior to C1D1.
  • Targeted therapy including antiangiogenic therapy