TheranosticTrials.org

Clinical Trial · NCT06343038

Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study

Overview

Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before. In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time. The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects. The performance of different prostate cancer diagnostic methods is also in scope of the study.

Sponsor

University Hospital, Basel, Switzerland

Phase

Phase 1

Contacts

Alin Chirindel, MD (CONTACT)

alin.chirindel@usb.ch

+41 61 328 63 75

Alin Chirindel, MD (PRINCIPAL_INVESTIGATOR)

Damian Wild, MD (CONTACT)

damian.wild@usb.ch

+41 61 328 66 83

ClinicalTrials.gov

NCT06343038

Drug / Compound

PSMA-I&T

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

SibuDAB

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

Eligibility

Inclusion

  • Albumin \> 25 g/L
  • Clinical indication for RLT with 177Lu-PSMA-I\&T (progressive PSMA-positive mCRPC patients after androgen receptor signalling pathway inhibitor and taxan-based chemotherapy or patient unfit for chemotherapy)
  • Patients will be included in Phase Ia while being under active therapy with 177Lu-PSMA-I\&T (SoC) and after they have completed the first two cycles of 177Lu-PSMA-I\&T RLT
  • For male patients who are not surgically sterilized (orchiectomy or vasectomy), appropriate contraceptive measures must be taken during RLT and until 4 months after completion of RLT. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)
  • Consent form signed
  • At least 3 measurable tumours on PSMA PET/CT (\>1.5 cm) with sufficiently intense PSMA uptake (SUVmax\>20)
  • Bilirubin ≤ 2 times upper standard value
  • Estimated glomerular filtration rate (eGFR) \> 45 ml/min
  • ALT, AST, AP: ≤ 5 times upper standard value
  • Blood parameters: a) Leucocytes ≥ 3 G/L; b) Haemoglobin ≥ 100 g/L; c) Thrombocytes ≥ 100 G/L
  • ECOG Performance status: 0-1

Exclusion

  • Ongoing infection at the screening visit or a serious infection in the past 4 weeks
  • Administration of another investigational product in the last 60 days before Visit 1 Day 1
  • Prior PSMA-targeted RLT (except for the 2 first cycles in Part Ia)
  • Any extensive radiotherapy involving bone marrow over the last 3 months before inclusion to the study
  • Known intolerance against DOTA, DOTAGA, urea-based analogues or against any of the components/formulation of 177Lu-PSMA-I\&T or 161Tb-SibuDAB solutions.
  • Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus \[HbA1c ≥ 9%\], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.
  • PSMA-negative (or PSMA-negative / FDG-positive) disease
  • Chemotherapy in the last 4 weeks before inclusion
  • Prior or planed administration of a therapeutic radiopharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
  • Current history of any malignancy other than prostate cancer within 5 years of enrolment except for fully resected non-melanoma skin cancer