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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAdministration of ceralasertib and Administration of ceralasertib in combination with olaparib

Plus 6 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 24, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?28 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Principal
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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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