A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC

The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in par

Trial Details

NCT ID
NCT07226986
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • AMO959
  • AAA617
  • Enzalutamide
  • Abiraterone
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • El Paso, Texas, United States|31.75872,-106.48693
  • Murray, Utah, United States|40.66689,-111.88799
  • Malvern, Victoria, Australia|-37.86259,145.02811
  • Melbourne, Victoria, Australia|-37.814,144.96332

Key Eligibility 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 of 0 to 2.
  • Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g. neuroendocrine, intraductal…

For full eligibility, visit ClinicalTrials.gov.

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