About this trial

This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.

Eligibility criteria

Qualifiers

Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.

Age >= 18 years.

Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.

Patients must have adenocarcinoma histology.

Disqualifiers

Patients with small cell or neuroendocrine carcinoma histology.

Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue

Patients with prior treatment with CDK4/6 inhibitors

Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs) are eligible.

Trial design

Treatments tested in this trial

  • Abemaciclib
  • Lutetium Lu 177-PSMA-617

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
University of California, San Francisco94143, San FranciscoCalifornia, United States

Sponsors and collaborators

Vadim S Koshkin

Lead sponsor

University of California, San Francisco

Sponsor institution

Prostate Cancer Foundation

Collaborator

Eli Lilly and Company

Collaborator