Lorikeet Patient Summary – Metastatic Castration Resistant

Background Information:

Our immune system protects us from disease by killing bacteria and viruses. It also helps fight cancer. A T-cell is one type of immune cell that does this. T-cells have proteins on them that turn on the immune system when it needs to fight infection and other proteins that turn off the immune system when it is no longer needed. These proteins are called checkpoints. Cancer cells can trick the immune system by turning off the T-cells, stopping them from recognizing the cancer cells. Drugs called “checkpoint inhibitors” turn back on the T-cells so they can recognize and attack the cancer cells.

Lorigerlimab is an investigational drug being tested in clinical trials. It is designed to block two checkpoints, telling the immune system cells to wake up and start killing cancer cells. Checkpoint inhibitors, including lorigerlimab, may cause side effects.

Understanding the LORIKEET Clinical Trial for Advanced (Metastatic Castration-Resistant) Prostate Cancer

Overview

The LORIKEET Clinical Trial is studying lorigerlimab in people with metastatic castration-resistant prostate cancer (mCRPC). This Phase 2 study will compare the effectiveness and side effects of lorigerlimab given in combination with docetaxel and prednisone with the effectiveness and side effects of docetaxel and prednisone alone.

Who Can Join (Inclusion Criteria):

Adults over 18 with metastatic castration-resistant prostate cancer (mCRPC) which has evidence of spreading demonstrated by a either a CT, MRI, or bone scan taken within the past 28 days who meet the following criteria may be eligible to participate in the LORIKEET clinical trial.  To be eligible to join:

1. Previous Treatments:

• You have been treated once and no more than twice with either abiraterone, enzalutamide, apalutamide, or darolutamide.
• Prior treatment with PARP inhibitors (like olaparib) is allowed.
  • For those with a BRCA mutation, trying an approved PARP inhibitor is necessary.
• You have NOT received chemotherapy for metastatic CRPC.
  • However, if you took a drug called docetaxel before your prostate cancer advanced and it worked for at least a year, you still may be eligible for the trial.
• You have NOT been treated with checkpoint inhibitors

2. Cancer Growth: Your cancer is growing based on certain criteria (PCWG3).
3. Your Health and Body’s Function:

• Blood tests need to show:
  • Platelets over 100.
  • ANC over 1.5.
  • Hemoglobin over 9 g/dL.
  • Liver tests should be mostly normal.
  • Your kidneys should be working well; you need a creatinine clearance over 50 mL/min.

 Things that prevent you from joining (Exclusion Criteria):

1. Recent Treatments or Procedures:
   • No major surgeries in the last 4 weeks.
   • No chest or pelvic radiation in the last 4 weeks. But a small radiation treatment for pain or symptoms is okay if it was at least 2 weeks ago.
   • Haven’t used products known to lower PSA levels, like saw palmetto, in the last 4 weeks.
2. Other Cancers: If you had another cancer that was stage 1 or higher and you finished treatment for it less than 2 years ago, you cannot join. But if you had a minor skin cancer or a very local cancer and it was fully treated, you may be eligible.
3. Infections: If you have an infection needing treatment in the last week, you cannot join.

 There are more requirements about who can or cannot join. The study team will tell you all about them.

What Will Happen in the Study?

1. First, doctors will check if you can join the study.
2. If you are eligible to join, you will be randomly selected to receive either:

• Lorigerlimab intravenously (in the vein) every three weeks up to 35 times and docetaxel/prednisone up to 10 times OR
• Docetaxel/prednisone up to 10 times

3. Doctors will check you often to see how your treatment is working and will monitor you for side effects.

 Considerations for participating in LORIKEET:

• Clinical trials are an essential step in the process of developing new medications.
• Participants in clinical trials help us learn if investigational study drugs are effective and tolerable for the treatment of diseases.
• Lorigerlimab is still being tested, so we don’t know all its benefits and risks yet.
• All clinical studies and medical treatments come with some risks.
• There is no guarantee that you will receive any benefit from being in a study, but your participation may help other people living with the same disease in the future.

Want to Learn More?  If you are interested in finding out more about participating in LORIKEET, talk with your health care team about the benefits and risks.

Organization:

MacroGenics

 Clinicaltrials.gov Information:

• NCT Number: NCT05848011
• Title: A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.

Register your interest or comments about this trial with PHEN

Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.