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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

NCT06343038 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Castration-resistant Prostate Cancer

Interventions

DRUG

Injection, 161Tb-SibuDAB,1GBq

Intravenous injection via peripheral venous catheter of \~1GBq 161Tb-SibuDAB (\~200 μg / \~125 nM) in saline

DRUG

Injection, 177Lu-PSMA-I&T, 1GBq

Intravenous injection via peripheral venous catheter of \~1GBq 161Tb-SibuDAB (\~100 μg / \~65 nM) in saline

DRUG

Injection, 161Tb-SibuDAB, Dose Escalation

Intravenous injection via peripheral venous catheter of 161Tb-SibuDAB in saline. The intervention comprises 4 cycles at 6-week intervals. The 161Tb-SibuDAB entry activity will be calculated based on dosimetry and toxicity data from the first 3 patients in Phase Ia of the study. The escalated or de-escalated 161Tb-SibuDAB activity for the subsequent 3-patient cohorts will be determined based on the clinical and biochemical safety information and on organ dosimetry results of the entry/previous cohort. Up to 4 escalation or de-escalation steps will be performed.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Alin Chirindel, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343038 on ClinicalTrials.gov