OncoMatch/Clinical Trials/NCT06780670
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Is NCT06780670 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including Investigators choice of SoC and AAA817 for prostate cancer.
Treatment: Investigators choice of SoC · AAA817 · AAA817 · AAA817 — This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 psma-positive
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen receptor pathway inhibitor
Prior treatments with an androgen receptor pathway inhibitor (ARPI)
Must have received: taxane
Prior treatments with ... taxane-based chemotherapy
Must have received: PSMA-targeted radioligand therapy ([177Lu]Lu-PSMA)
progressed on or after [177Lu]Lu-PSMA targeted therapy
Cannot have received: investigational agent
Any investigational agents within 28 days prior to the day of randomization
Cannot have received: 225Ac-based investigational compound
Any 225Ac-based investigational compound used prior to the day of randomization
Lab requirements
Kidney function
egfr as requested by the sponsor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- VA Greater LA Healthcare System · Los Angeles, California
- University Cancer and Blood Center LLC · Athens, Georgia
- Indiana University · Indianapolis, Indiana
- University of Kansas Hospital · Kansas City, Kansas
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06780670 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent, 225Ac-based investigational compound disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 psma-positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger.
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