Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age20+
SponsorNational Taiwan University Hospital
About this trial
This study is a phase I dose escalation clinical trial aims to evaluate 161Tb-PSMA-I\&T, a new generation prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) using Terbium-161 to replace Lutetium-177, its safety, dosimetry, biodistribution, pharmacokinetics, and preliminary efficacy in Taiwanese men with metastatic castration-resistant prostate cancer, and to inform future clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 20 years, ability to understand and willingness to sign informed consent, cooperate with all study-related procedures and assessments including blood tests and imaging
Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC)
Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone analog, with a serum testosterone level <50 ng/dL (castrate range)
Prior treated with at least one line of taxane-based chemotherapy unless medically unsuitable, and at least one line of androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)
Disqualifiers
History of allergic reaction to PSMA-targeted compounds or radiometals
Prior radioligand therapy with 223Ra or 177Lu-PSMA within 6 months
Prior surgery or radiotherapy within 4 weeks prior to first investigational dose
Prior systemic therapies against prostate cancer within 4 weeks, including androgen receptor pathway inhibitor, chemotherapy, targeted therapy such as PARP inhibitors (PARPi)
Trial design
Design model
Sequential
Treatments tested in this trial
161Tb-PSMA-I&T
Drug161Tb-PSMA-I\&T for injections, slow intravenous administration, 200 mCi/5 mL/Vial
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Dose level 1Experimental treatment 1 intervention
Group B: Dose level 2Experimental treatment 1 intervention
Group C: Dose level 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-emergent adverse events
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 across the entire treatment and 18-week post-treatment surveillance period
Time frame
From enrollment to the end of post-treatment surveillance, at least 36 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov