A Phase 1 Clinical Study of NXP800 in Patients with Advanced Cancers
Research type
Research Study
Full title
A Phase 1 Clinical Study of NXP800 in Patients with Advanced Cancers
IRAS ID
305244
Contact name
Shay Shemesh
Contact email
Sponsor organisation
Nuvectis Pharma, Inc.
Eudract number
2021-004071-14
Clinicaltrials.gov Identifier
CPMS ID, 50382
Duration of Study in the UK
3 years, 11 months, 12 days
Research summary
This clinical trial is looking at (researching) a drug called NXP800. This is a new drug similar to a chemotherapy, which looks promising in laboratory studies. We think it acts by blocking a protective mechanism (the Heat Shock Factor or HSF-1 pathway) used by cancer cells. We now wish to find out if it will be useful in treating patients with cancer.
The three main aims of this clinical trial are to find out:
• The maximum dose that can be given safely to patients.
• More about the potential side effects of NXP800 and how they can be managed.
• What happens to NXP800 inside the body.This information will help us decide how much and how often to give NXP800 to patients in future clinical trials.
In total we plan to recruit up to approximately 90 patients. Approximately up to 5 hospitals in the UK are taking part in this clinical study; more may take part if we feel this is necessary.
The initial part of the clinical trial is a ‘dose escalation phase’ where groups of patients will receive increasing doses of NXP800 to find a dose that best targets cancer cells and that can be taken with limited side effects.
The later phase of the trial is an “expansion phase” where patients with specific cancer types will receive the dose of NXP800 found to be tolerated in the dose escalation phase, to find out more about how the drug is working. The use of NXP800 in this research study is experimental, which means than it is not approved by regulatory authorities (i.e., not available for commercial sale).
NXP800 has not been used in humans before.REC name
London - Central Research Ethics Committee
REC reference
21/LO/0806
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion