A Phase 1 Study of AZD4785 in Patients with Advanced Solid Tumours
Research type
Research Study
Full title
A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD4785 in Patients with Advanced Solid Tumours Where KRAS May Be an Important Driver of Tumour Survival
IRAS ID
230587
Contact name
Henrik Hansson
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-004630-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 28 days
Research summary
This is a Phase 1, international, multicentre study of AZD4785 in patients with advanced solid tumours where KRAS may be an important driver of tumour survival. This first in human study will be conducted in two parts: a dose escalation phase (Part A) and a dose expansion phase (Part B).
AZD4785 will be given intravenously (IV) as an infusion over 1 hour. Each 28 day period (4 weeks) will be called a cycle. Study treatment with AZD4785 will be administered in 3 loading doses during the first week and then one dose weekly thereafter. Patients continuing beyond Cycle 1 will receive AZD4785 weekly until disease progression, intolerable toxicity, or discontinuation criteria have been met. Other dosing schedules may be evaluated based on the emerging PK and safety data.
In Part A, patients will be enrolled to ensure a minimum of 3 and a maximum of 6 evaluable patients per cohort. During Part A, data will be evaluated on an ongoing basis. The study will also characterise the pharmacokinetic (PK) profile of AZD4785 monotherapy and will explore the potential biological activity by assessing preliminary anti-tumour activity in patients.
Once the maximum tolerated dose is established, Part B will explore PK parameters, safety, tolerability and preliminary anti-tumour activity of AZD4785 in patients with NSCLC. Two groups of 10 patients with NSCLC will be enrolled into Part B. Group 1 has the option to provide tumour biopsies while Group 2 is required to provide paired tumor biopsies. A third group of patients with other tumour types may be added based on results seen in Parts A and B and other emerging data.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0255
Date of REC Opinion
11 Oct 2017
REC opinion
Further Information Favourable Opinion