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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 (May 2026). This Phase 2/3 trial studies multiple treatments including Investigators choice of SoC and AAA817 for prostate cancer.

Phase 2/3RecruitingNovartis PharmaceuticalsNCT06780670Data as of May 2026

Treatment: Investigators choice of SoC · AAA817 · AAA817 · AAA817This 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

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Extracted eligibility criteria

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)

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 →

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