Harpoon Therapeutics has treated the first patient in a Phase l clinical trial to investigate the safety, tolerability and pharmacokinetics of HPN424 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
The multicentre, multinational, open-label, ascending-dose trial aims to enrol around 40 metastatic prostate cancer patients.
In the first stage of the trial, patients will receive a once-weekly dose of HPN424 via intravenous (IV) infusion with dose escalation until a therapeutic dose level has been reached.
After completing the dose-escalation phase, Harpoon is expected to further analyse the safety and efficacy of HPN424 in a Phase ll trial by including additional cohorts of patients to administer the recommended dose established in the first phase of the Phase l trial.
Harpoon Therapeutics president and CEO Jerry McMahon said: “HPN424 is the first Tri-specific T-cell Activating Construct (TriTAC) compound to enter clinical testing and represents a novel class of T-cell therapeutics aiming to achieve superior efficacy in penetrating and killing solid tumours.
“Data is expected in 2019, and should provide the safety assessment, pharmacokinetics and pharmacodynamics to determine the optimal dose and regimen for our additional planned trials in prostate cancer, the third leading cause of cancer deaths for men in the US.”
Around 26,000 men in the US are currently estimated to die from prostate cancer after receiving treatment with the available therapies.
HPN424 is an investigation compound designed as a new T-cell therapy that can overcome the loss of human leukocyte antigen (HLA) expression, a common means used by cancer cells to escape T-cell recognition.