A Study to Administer Increasing Doses of NMS-03305293 to Patients with Advanced Solid Tumors
Research type
Research Study
Full title
A Phase I Dose Escalation Study of NMS-03305293 in Adult Patients with Selected Advanced/Metastatic Solid Tumors
IRAS ID
1005974
Contact name
Samuela Soza
Contact email
Sponsor organisation
Nerviano Medical Sciences S.r.l
Eudract number
2018-003918-40
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to find out about the safety and efficacy of a new drug called NMS-03305293, for the treatment of solid tumours. This is a First in Human study with NMS-03305293.
NMS-03305293 belongs to the family of compounds called PARP inhibitors and acts by blocking a specific enzyme called PARP-1, a protein involved in many functions of the cell, including the repair of DNA when it becomes damaged.
PARP inhibitors are a type of targeted therapy being studied in the treatment of cancer because they prevent repair of damaged DNA causing cell death preferentially in cancer cells, which grow faster than non-cancerous cells.
The study is designed in two parts: dose-escalation and dose expansion. The study will be done in adult patients with epithelial ovarian, HER2 negative breast cancer, pancreatic cancer, or castration resistant prostate cancer, who have exhausted standard treatment options, or for whom standard therapy is considered unsuitable.
A number of tests and procedures will be done at the study visits, including: physical examinations, collection of blood and urine samples for laboratory tests, ECGs (electrical test of the heart rhythm), CT/MRI scans and completion of diaries.
The study is being conducted in Europe, the USA and China, and it is expected that a total of about 50 patients will participate in the dose escalation part, and up to 75 patients will participate in the dose expansion part.
The study is sponsored by Nerviano Medical Sciences S.r.l.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0043
Date of REC Opinion
15 Mar 2023
REC opinion
Further Information Favourable Opinion