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
Summary of Research
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.Summary of Results
1. GENERAL INFORMATION
Nuvectis Pharma, Inc., the study sponsor, thanks the participants who took part in this study.
This is a summary of the research findings from the study entitled, “A multi-center, first-in-human, open label, dose escalation and expansion Phase 1 study in subjects with advanced solid tumors and in subjects with ovarian cancer”. This research was organized and funded by Nuvectis Pharma, Inc., a biopharmaceutical company located in the United States of America (USA). The study was conducted in clinical sites in the United Kingdom and USA. No sites in the European Union (EU) enrolled subject in the study.
In this study, several doses of the investigational drug NXP800 were tested to evaluate its side effect profile and the behavior of it in the body in patients with various advanced cancers. Subsequently, the activity of NXP800 was investigated in patients with certain ovarian cancers.
2. WHO PARTICIPATED IN THE STUDY?
A total of 45 patients participated in the study, including 27 with ovarian cancer from January 2022 to January 2026.
3. WHAT TREATMENTS OR INTERVENTIONS DID THE PARTICIPANTS TAKE/RECEIVE?
All study participants were administered NXP800 as monotherapy (no other treatment).
4. WHAT MEDICAL PROBLEMS (ADVERSE REACTIONS) DID THE PARTICIPANTS HAVE?
The most common adverse reactions included nausea, vomiting, diarrhea, fatigue and decreased appetite. Changes in blood tests that check how the liver is working including increases in enzymes called AST and ALT, reduction in platelets (cells that help blood to clot), and anemia.
5. WHAT HAPPENED DURING THE STUDY?
In the first portion of the study, doses of NXP800 that can be administered in further research were identified. The second portion of the study was terminated by the Sponsor due to the feasibility of further clinical development of NXP800 in this patient population.
6. DETAILS OF ANY FURTHER RESEARCH PLANNED
No further research is planned at this time.
7. WHERE CAN I LEARN MORE ABOUT THIS STUDY?
2023 AACR-NCI-EORTC conference. Reference: Rodney (2023): Results of a phase 1 dose escalation clinical trial of NXP800, a novel GCN2 activator, in patients with advanced solid tumors.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