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

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Investigators choice of SoC — DRUG
  The control treatment in Phase III is investigator's choice of SoC
• AAA817 — DRUG
  The investigational treatment is AAA817
• AAA817 — DRUG
  The investigational treatment is AAA817
• AAA817 — DRUG
  Investigational treatment is the Dose B of AAA817

Study Details

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

Key Dates

First listed

Jan 17, 2025

Start date

Feb 27, 2025

Status verified

Sep 2026

Primary completion

Jun 27, 2028

Completion

Jul 19, 2033

Study Design

Enrollment

443 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase II: AAA817 Dose B
  AAA817 will be given for a number of cycles; a cycle = 8 weeks
• Active Comparator: Phase III: Investigator's choice of SoC
  Participants will be given Standard of Care (SOC) treatment per Investigator's choice.
• Experimental: Phase II: AAA817 Dose A
  AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks
• Experimental: Phase III: Recommended Phase 3 Dose of AAA817
  Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks

Primary Outcome Measure

Biochemical response rate (Phase II) [ Time Frame: from date of randomization up to approximately 24 months ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (35)

Find similar trials in Scottsdale, AZ

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