NB003-01
Research type
Research Study
Full title
A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Malignancies
IRAS ID
1007279
Contact name
Esha Dasgupta
Contact email
Sponsor organisation
Ningbo Newbay Technology Development Co. Ltd.
Clinicaltrials.gov Identifier
Research summary
This study will look at participants with gastrointestinal stromal tumours or other cancers where the tumour cannot be surgically removed, or has come back after treatment, or has spread to another part of the body. Main purpose is to determine the safety, tolerability, efficacy, to find out the maximum tolerated dose (highest dose of the study drug that can be given to people without causing unacceptable side effects) of the study drug, and to define the recommended dose to be used in future studies. The study will also look at what the body does to the study drug (known as ‘pharmacokinetics’ or ‘PK’). This is a Phase 1 study, which means it is the first time the study drug has been given to people. The study has 2 parts and will consist of 3 periods: a screening period, a treatment period, and a follow-up period: Dose escalation phase is where the drug dose will gradually increase with each group of enrolled participants to help to determine how safe the study drug is, the levels of the study drug in the bloodstream, and a dose for the next phase of the study and
Dose expansion phase: To further study the recommended dose from the previous phase in a larger group of participants, including those with GIST, melanoma, and other advanced cancers; explore how safe the study drug is, the levels of the study drug in the bloodstream, and antitumour effect of study drug. Since this is a first in human study, there may be other possible discomforts, side effects, and risks to using NB003 that is still unknown. Sometimes during a study, the sponsor may learn new information about the study drug and the risks, which the study doctor will tell the participant about in a timely manner. If a participant is interested to take part in the study, the consent forms will need to be signed and the participant will take part in the study procedures as per study protocol. During this study, samples of blood, urine, and tissue will be taken as a part of study procedure.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0275
Date of REC Opinion
20 Jun 2023
REC opinion
Further Information Favourable Opinion