* Study of AMG 757 in Patients with Neuroendocrine Prostate Cancer
Research type
Research Study
Full title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects with De Novo or Treatment Emergent Neuroendocrine Prostate Cancer
IRAS ID
291322
Contact name
Adam Sharp
Contact email
Sponsor organisation
Amgen
Eudract number
2020-003508-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 25 days
Research summary
Neuroendocrine Prostate Cancer (NEPC) represents an aggressive form of prostate cancer. The prognosis for NEPC is poor and is often treated with chemotherapy. There is currently no standard therapeutic approach and it remains an unmet need. AMG 757 an antibody which sticks to both cancer cells and T-cells. Antibodies are proteins that are produced by the immune system to help stop intruders from harming the body. T-cells are immune cells that are known to fight cancer, but cancer cells often hide from T-cells. AMG 757 works by bringing the body’s own T-cells into direct contact with the cancer cells and helps to kill them.
The primary objectives of this study are to evaluate the safety and tolerability of AMG 757 and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) in male participants aged ≥ 18 years, with de novo (the first occurrence of cancer in the body) or treatment-emergent (those symptoms which arise once therapy occurs) NEPC.
Approximately 60 participants will be enrolled in this open label study. Up to 20 participants will be enrolled in the dose exploration phase (Part 1) and 40 participants will be enrolled in the dose expansion phase (Part 2). The study duration for participants will be approximately up to 3 years. The study duration will consist of up to 28 days for screening, a variable period on treatment, and a safety follow-up period of up to approximately 42 days after the last dose of AMG 757. For all subjects who have not withdrawn consent, long-term follow-up assessment will also be conducted every 3 months up to 3 years from the first dose of AMG 757. Approximately 25 investigative sites in the US, Europe, and Australia will be included in the study.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0146
Date of REC Opinion
5 Nov 2021
REC opinion
Further Information Favourable Opinion