Recruiting
Phase 1

Lutetium (177Lu)

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06531499

Conditions

Metastatic Castration-Resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AAA617

Gonadotropin-releasing hormone (GnRH) analogues

Gonadotropin-releasing hormone (GnRH) antagonists

Study Details

Brief summary:

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

Conditions

Metastatic Castration-Resistant Prostate Cancer

Study ID

NCT06531499

Start date

Nov 11, 2024

Status verified date

Dec, 2025

Completion date

Nov 24, 2028

Anticipated

Primary completion date

Nov 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Participants must be adults ≥ 18 years of age.
  • Participants must have an ECOG performance status ≤ 1.
  • Participants must have histological confirmation of adenocarcinoma of the prostate.
  • Participants must be PSMA-positive per 68Ga-PSMA PET/CT scans at baseline
  • Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L) either by pharmaceutical or surgical methods.
  • Participants must have progressed only once on prior second generation ARPIs
  • Documented progressive mCRPC
  • Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening/baseline CT, MRI, or bone scan
  • Renal: eGFR ≥ 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia.

Key exclusion Criteria:

  • Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
  • Any previous radioligand therapy.
  • Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \[including monoclonal antibodies\]. \[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\].
  • Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy
  • History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
  • Concurrent serious acute or chronic nephropathy and/or moderate to severe renal impairment as determined by the principal investigator.
  • Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment
  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment.
  • Concurrent urinary outflow obstruction or unmanageable urinary incontinence
  • History of somatic or psychiatric disease/condition that may interfere with the aims and assessments of the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

106 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AAA617

All participants will receive the investigational product AAA617 (7.4 GBq ±10%).

Interventions

AAA617

\[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for up to 12 cycles.

Gonadotropin-releasing hormone (GnRH) analogues

Anatomical Therapeutic Chemical \[ATC\] code L02AE

Gonadotropin-releasing hormone (GnRH) antagonists

Degarelix, Relugolix

Primary outcome measure

  • Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs [ Time Frame: From Cycle 1 to Cycle 12; cycle = 42 days ]
  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: For up to 12 cycles in taxane-naive participants with progressive PSMA-positive mCRPC with nrmal kidney function or mild renal impairment; cycle = 42 days ]
  • Percentage of participants with AAA617 dose reductions, interruptions and discontinuations [ Time Frame: Up to 42 (+7) days after last AAA617 dose administration (Safety Follow-up) ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

University of California LA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Stephanie Lira

StephanieLira@mednet.ucla.edu

Principal Investigator:

Matthew Rettig

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kavin Tamizhmani

ktamizhm@stanford.edu

Principal Investigator:

Hong Song

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Noah Uhlenkamp

507-538-2155Uhlenkamp.Noah@mayo.edu

Principal Investigator:

Daniel Childs

Wash U School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jennifer Frye

fryej@wustl.edu

Principal Investigator:

Vikas Prasad

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Marlene Bridwell

402-691-6972mbridwell@nebraskacancer.com

Principal Investigator:

Samuel Mehr

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

  • Phase 1
  • RADIODOSE
  • AAA617
  • metastatic castration-resistant prostate cancer
  • radiation dosimetry
  • mCRPC
  • Prostate-specific membrane antigen (PSMA)
  • Dosimetry
  • [68Ga]Ga-PSMA-11
  • gallium (68Ga) gozetotide
  • [177Lu]Lu-PSMA-617
  • lutetium (177Lu) vipivotide tetraxetan
  • Radioligand Imaging (RLI)
  • Radioligand Therapy (RLT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2025-12-31.