HPN424 in Patients with Advanced Prostate Cancer
Research type
Research Study
Full title
A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy
IRAS ID
246386
Contact name
Johann de Bono
Contact email
Sponsor organisation
Harpoon Therapeutics, Inc.
Eudract number
2018-000135-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 22 days
Research summary
This is a Phase 1/2a, open-label, multicentre, dose escalation, and dose expansion, safety and pharmacokinetic (PK) study of an investigational drug called HPN424 in adult participants with cancer of the prostate (a type called progressive metastatic castrate-resistant prostate cancer - mCRPC) and in the opinion of the investigator is in need of a new treatment. Approximately 90% of mCRPC patients develop bone metastases. Therapeutic options are currently limited for this advanced prostate cancer and existing therapies do not offer resolution of the bone lesions.
HPN424 has been developed by Harpoon Therapeutics Inc., and it is intended to redirect human T cells (a type of white blood cell) in the body to kill prostate cancer cells in patients with this type of cancer. This is the first clinical study of HPN424. Non-clinical data suggests HPN424 has substantial anticancer activity in preclinical models. The toxicity profile seen in nonclinical studies of HPN424 is consistent with its target expected activity. This data supports the clinical development of HPN424 for the treatment of patients with mCRPC.
This study will be divided into 2 parts: Dose Escalation (Part 1)- to evaluate safety and tolerability of increasing doses of HPN424 and to select the dose for Part 2. The Dose Expansion (Part 2)- will test the clinical effectiveness of the chosen dose. As an added safety measure for this first in human (FIH) trial, single patient cohorts will initially
be enrolled and treated. Dose Escalation will then proceed (2 treatment arms in parallel). 110 patients with mCRPC will take part in this study at approximately four sites (1 UK and 3 in the USA). Patient will participate for approximately 36 months and undergo a number of assessments including; physical exams; blood sampling; tumour assessments etc., to see if the study drug is having an effect on their tumours.REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1247
Date of REC Opinion
19 Sep 2018
REC opinion
Favourable Opinion