Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

About the study

This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin. The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab. The fourth module will investigate the effect of food on ceralasertib absorption and the effect of ceralasertib on ECG parameter. The fifth module to be investigated is ceralasertib with AZD5305.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Principal Inclusion criteria:

Aged at least 18
The presence of a solid malignant tumour that is not considered appropriate for further standard treatment
Module 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan
Module 2 Part B All (except B5): No previous treatment with PARP inhibitor.
Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours
Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours
Module 2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer
Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC)
Module 2 Part B5 Study expansion: BRCAm or RAD51C/Dm or PALB2m or HRD positive status ovarian cancer patient who are Platinum Sensitive Relapsed and have previously progressed on a licensed PARPi
Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma
Module 4: any advanced solid tumours except gastric, gastro-oesophageal, oesophageal or colorectal cancer with a small bowel resection
Module 4: Ability to comply with an overnight fast of at least 10 hours prior to dosing and 4 hours after dosing as mandated, and ability to eat a high fat meal as mandated
Module 5 All: Ovarian fallopian tube or primary peritonial cancer, previous treatment with PARP inhibitor, platinum-sensitive relapsed ovarian cancer
Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status

EXCLUSION CRITERIA

Principal exclusion criteria

A diagnosis of ataxia telangiectasia
Prior exposure to an ATR inhibitor
Bad reaction to ceralasertib
Module 2: Contra-indicated for treatment with olaparib
Module 3: Contra-indicated for treatment with durvalumab
Module 4: Mean resting corrected QT interval (QTc) >470 msec or history of familial long QT syndrome.
Module 4: Patients with type I or type II diabetes
Module 5: Known hypersensitivity to PARP including AZD5305

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer

Age (in years)

18 - 130

Phase

Phase 1/Phase 2

Participants needed

466

Est. Completion Date

Aug 5, 2026

Treatment type

Interventional

Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT02264678

Study number

D5330C00004

Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?