Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T

NCT07621692 | Recruiting Phase 1

• 1 other identifier: 202507234MINB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Keywords

Radioligand therapy; Terbium-161; Prostate-specific Membrane Antigen (PSMA); Metastatic Castration Resistant Prostate Cancer (mCRPC)

Outcome Measures

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

  From enrollment to the end of post-treatment surveillance, at least 36 weeks

Study Arms (3)

Dose level 1

EXPERIMENTAL

120 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles

Drug: 161Tb-PSMA-I&T

Dose level 2

EXPERIMENTAL

150 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles

Drug: 161Tb-PSMA-I&T

Dose level 3

EXPERIMENTAL

200 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles

Drug: 161Tb-PSMA-I&T

Interventions

161Tb-PSMA-I&T DRUG

161Tb-PSMA-I\&T for injections, slow intravenous administration, 200 mCi/5 mL/Vial

Dose level 1; Dose level 2; Dose level 3

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient
• Progressive disease defined according to Prostate Cancer Clinical Trials Working Group 3: Either a PSA progression of more than 2 rising PSA values from baseline with intervals ≥ 1 week, or a soft-tissue progression on images per RECIST 1.1 criteria, or a bone progression on images with more than 2 new lesions
• Evidence of significant PSMA-avid lesions on 68Ga- or 18F-labeled PSMA PET/CT within 12 weeks prior to screening, which defined as 68Ga-PSMA or 18F-PSMA uptake greater than that of liver or spleen parenchyma (depend on the tracer used) in at least one metastatic lesion of any size in any organ system
• A life expectancy of ≥ 6 months and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate bone marrow and organ functions 9.1 Hemoglobin ≥ 10 g/dL without RBC transfusion within 4 weeks 9.2 Absolute neutrophil count ≥ 1.5 × 109/L 9.3 Platelet count ≥ 150 × 109/L 9.4 Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault) 9.5 AST and ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN
• Willingness to comply with the use of medically acceptable forms of barrier contraception if sexually active

You may not qualify if:

• 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)
• Discordant disease on PET images: FDG-positive disease with minimal PSMA expression
• Urinary tract obstruction causing hydronephrosis unless appropriately treated beforehand
• Known symptomatic brain metastases or leptomeningeal disease, symptomatic or impending cord compression unless appropriately treated beforehand
• Other active malignancy requiring systemic treatment
• Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina)
• Concurrent severe uncontrolled illness that may jeopardize patient safety, including uncontrolled infections

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Ching-Chu Lu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Ju Chuang

CONTACT

+886-2-2322-0322; pjchuang.ntucc@gmail.com

Ching-Chu Lu

CONTACT

+886-2-2312-3456; kelvinlu@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dose escalation with 3 dose levels

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: June 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)