Actively Recruiting
A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC
Led by Radiopharm Theranostics, Ltd · Updated on 2026-04-01
73
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1/2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-KLK3 Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants with Castration-Resistant Prostate Cancer (CRPC).
CONDITIONS
Official Title
A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants 18 years of age or older
- Willing and able to provide informed consent and comply with study procedures
- Histopathologically confirmed locally advanced or metastatic castration-resistant prostate cancer with documented progression
- PSMA PET-positive disease with at least one metastatic lesion showing uptake greater than liver tissue
- Progression after androgen deprivation therapy and at least one androgen receptor signaling inhibitor
- Prior treatment with up to 6 doses of lutetium-177-PSMA radioligand allowed
- Prior treatment with no more than one taxane-based chemotherapy allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 4 months
- Agreement to use effective contraception and not donate sperm during the study and for 6 months after last dose
- Participants with treated, stable brain metastases meeting specified neurological and imaging criteria
You will not qualify if you...
- Prostate cancer with significant sarcomatoid, spindle cell, neuroendocrine small cell components, or metastasis from other cancers
- History of prior organ transplant except corneal transplant
- Active malignancy other than non-melanoma skin cancer or adequately treated low-risk bladder cancer
- Medical conditions preventing full study participation due to safety or compliance concerns
- Residual toxicity Grade 2 or higher from prior anticancer therapy except alopecia and peripheral neuropathy
- History of uncontrolled allergic reactions or known hypersensitivity to 161Tb-RAD402 or related proteins
- Poor organ function defined by specific laboratory thresholds (e.g., low eGFR, low blood counts, elevated liver enzymes)
- Blood transfusion within 2 weeks prior to first dose
- Significant cardiovascular disease including unstable angina, recent heart attack, heart failure, significant ECG abnormalities, low ejection fraction, or long QT syndrome
- Participation in another interventional cancer trial at consent
- Major surgery within 4 weeks prior to first dose
- Prior treatment with PARP inhibitors or radium Ra 223 dichloride
- Anti-cancer therapy within 28 days prior to first dose except for prior Lu-177-PSMA radioligand allowed
- Active hepatitis B or C infection, or uncontrolled infections
- Untreated moderate to severe hydronephrosis
- Superscans on bone scan
- Active autoimmune disease requiring recent systemic treatment
- Other significant comorbidities or conditions that could impact safety or study integrity
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
2
Icon Cancer Centre Hollywood
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
D
Dimitris Voliotis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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