XCancer

Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer

Description:

This study is an open label Phase I/II study conducted according to a Fleming design, investigating the safety and the efficacy of 4 IV injections of 177Lu-PSMA-1 in patients with metastatic clear cell renal cancer. This trial is divided in 2 parts: * A safety run-in part aiming to assess the safety of 177Lu-PSMA-1 (with 6 patients treated at the starting activity = 7.4 GBq of 177Lu-PSMA-1, every 6 weeks (Q6W) for 4 administrations). If more than one patient experiences a ST during the first cycle of therapy (6 weeks), then a lower activity of 177Lu-PSMA-1 will be evaluated in an additional cohort of 6 patients (5.9 GBq). The 6 patients from this safety run-in step, treated at the activity selected for phase II, will be included in the evaluation of Phase II part. * A Phase II part aiming to assess the clinical activity of 177Lu-PSMA-1

Sponsor:

Centre Leon Berard

Phase:

Phase 1/2

Government Study Link:

NCT06059014 - Click here to see study on

ClinicalTrials.gov

PSMA-1

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

PSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Inclusion
  • For patient with both extra-hepatic and liver metastasis: ≥ 50% of positive extrahepatic metastatic lesions and ≥ 80 % of positive supracentimetric liver metastatic lesions.
  • For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic metastatic lesions
Exclusion
  • E1. Patients with known active central nervous system (CNS) metastases and/or epidural metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses higher than 10 mg/d of methylprednisolone or equivalent) for at least 4 weeks prior to C1D1.E2. Patients previously treated with any radiopharmaceutical, excluding 68Ga-PSMA required during screening for this protocol.E3. Persisting toxicities related to previous anti-cancer therapy which were not resolved to grade ≤1 (except: anaemia provided that criterion I7 is met) and /or any persistent irAE of any grade (except adequately controlled irAE (e.g: with replacement therapy for endocrine irAE)).E4. History, within 2 years, of cancer other than renal cancer, except for basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer.E5. History of idiopathic pulmonary fibrosis, non-infectious pneumonitis, interstitial lung disease that required steroids or has current pneumonitis, interstitial lung disease, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan.E6. Prior therapy or a need to be treated with a forbidden concomitant/concurrent therapies/procedure as defined per protocol.E7. Patients with clinically significant hematuria, hematemesis, or hemoptysis exceeding 0.5 teaspoon (2.5 mL) 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 since at least 2 weeks prior to C1D1.E8. Patients with an active uncontrolled infection. E9. Women pregnant or breastfeeding. E10. Patients placed under a legal protection regimen such as: Judicial Safeguards, curatorship or guardianship\-