OncoMatch/Clinical Trials/NCT05413850
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Is NCT05413850 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Lutetium (177Lu) rhPSMA-10.1 for prostate cancer.
Treatment: Lutetium (177Lu) rhPSMA-10.1 — To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) expression (positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen deprivation therapy
Cannot have received: psma targeted radionuclide therapy
Cannot have received: bone-targeted therapy (bisphosphonates)
Cannot have received: external beam irradiation to >30% of bone marrow or kidneys
Cannot have received: thoracic external beam radiotherapy
Cannot have received: strontium-89 (strontium-89)
Cannot have received: samarium-153 (samarium-153)
Cannot have received: rhenium 186 (rhenium 186)
Cannot have received: rhenium-188 (rhenium-188)
Cannot have received: radium-223 (radium-223)
Cannot have received: hemi-body irradiation
Lab requirements
Blood counts
adequate bone marrow reserve as demonstrated by blood count at baseline
Kidney function
adequate organ function as demonstrated by serum biochemistry at baseline
Liver function
adequate organ function as demonstrated by serum biochemistry at baseline
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Biogenix Molecular LLC · Miami, Florida
- NovaCure Health · Miami, Florida
- Emory University Hospital · Atlanta, Georgia
- XCancer Omaha / Urology Cancer Center · Omaha, Nebraska
- Weill Cornell Medicine - New York - Presbyterian Hospital · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05413850 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior psma targeted radionuclide therapy, bone-targeted therapy (bisphosphonates), external beam irradiation to >30% of bone marrow or kidneys disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 expression is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify