Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
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.
Checked against the public recordLast updated Jul 24, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: Administration of ceralasertib; Drug: Administration of ceralasertib in combination with olaparib; Drug: Administation of ceralasertib in combination with durvalumab; Drug: Administration of ceralasertib monotherapy; Drug: Administration of ceralasertib and olaparib; Drug: Administration of ceralasertib and durvalumab; Drug: Administration of ceralasertib in combination with AZD5305; Drug: Administration of ceralasertib in combination with carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteDuarte, California
- Research SiteIrvine, California
- Research SiteLos Angeles, California
- Research SiteLos Angeles, California
- Research SiteNewport Beach, California
- Research SiteBoston, Massachusetts
- Research SiteNew York, New York
- Research SitePhiladelphia, Pennsylvania
- Research SiteBordeaux
- Research SiteLyon
- Research SiteSaint-Herblain
- Research SiteVillejuif
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 24, 2026. Always confirm current availability with the study team.