OncoMatch/Clinical Trials/NCT05413850
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Is NCT05413850 recruiting? Yes, currently enrolling (Jun 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: FOLH1 overexpression (positive disease expression of PSMA as confirmed on PSMA PET/CT scan)
Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.
Excluded: FOLH1 negative disease expression
Presence of significant PSMA-negative disease on ceCT/MRI scan
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen deprivation therapy (Luteinising Hormone-releasing Hormone, GnRH) — castration
Serum testosterone levels <50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
Cannot have received: PSMA targeted radionuclide therapy
Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.
Cannot have received: bone-targeted therapy (bisphosphonates)
Ongoing treatment with bisphosphonates for bone-targeted therapy.
Cannot have received: external beam irradiation
Exception: to a field that includes more than 30% of the bone marrow or kidneys
Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.
Lab requirements
Blood counts
Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.
Kidney function
Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.
Liver function
Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.
Adequate bone marrow reserve and organ function as demonstrated by blood count, and 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
- 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, external beam irradiation disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 overexpression is a required biomarker for enrollment.
Are patients with FOLH1 alterations eligible?
No. FOLH1 negative disease expression is an exclusion criterion.
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 qualifyRelated pages