NZV930 in patients with advanced malignancies
Research type
Research Study
Full title
A Phase I/Ib, open-label, multi-centre study of NZV930 as a single agent and in combination with PDR001 and/or NIR178 in patients with advanced malignancies
IRAS ID
248004
Contact name
Alexander Chesi
Contact email
Sponsor organisation
Novartis Pharma Services
Eudract number
2018-000153-51
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 21 days
Research summary
This is a first in human (FIH) phase I/Ib open-label, multi-centre study of
NZV930 given on it's own or in combination with PDR001 and/or NIR178.
NZV930, PDR001 & NIR178 are experimental medicines and have not been approved by the regulatory authorities for the treatment of people with advanced cancer.
The study will enrol adult patients with advanced solid tumours i.e. non-small cell lung cancer, triple negative breast cancer, pancreatic cancer ,renal cell cancer, ovarian cancer, and colorectal cancer. Additional tumour types may be added based on emerging clinical data. The purpose of the study is to find the safest dose and treatment schedule that can be given safely to patients with advanced cancer.There are 2 parts to the study 1) Dose escalation part 2) Dose expansion part.
In the first part of the study, (dose escalation) , patients will receive
increasing doses of each study treatment to identify the recommended dose for the expansion, or second part of the study. Once the recommended dose (s) have been found then the dose expansion arms can begin.The frequency or how often patients receive NZV930 may also be evaluated using an “alternate dosing schedule.” At the beginning, participants will receive NZV930 every 2 weeks but, based on the emerging data, groups of patients may be given NZV930 study treatment weekly or every 4 weeks.
The decision to give NZV930 study treatment more or less often will be based on all the data collected up to that point.The combination arms of the expansion part (NZV930+NIR178, NZV930+PDR001,or
NZV930+PDR001+NIR178) will begin once all the recommended doses for the
combination treatments have been found. Participants enrolled to the expansion
combination arms will be randomised (allocated by chance) and classified by tumour type and whether they have received previous treatments (naïve or resistant) as appropriate.REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1846
Date of REC Opinion
10 Jan 2019
REC opinion
Further Information Favourable Opinion