Drugs / Ceralasertib
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Ceralasertib

Small molecule targets ATR via inhibition

Developed for
non-small cell lung carcinoma · cancer · female breast carcinoma · small cell lung carcinoma · triple-negative breast carcinoma · B-cell chronic lymphocytic leukemia · bile duct cancer · melanoma
+34 more · metastatic malignant neoplasm · refractory malignant neoplasm · castration-resistant prostate carcinoma · childhood malignant neoplasm · cholangiocarcinoma · clear cell renal carcinoma · colon carcinoma · diffuse large B-cell lymphoma · endometrial cancer · endometrial carcinoma · fallopian tube carcinoma · female reproductive organ cancer · gastric adenocarcinoma · gastric carcinoma · gastroesophageal junction adenocarcinoma · head and neck squamous cell carcinoma · hepatobiliary neoplasm · HER2 positive breast carcinoma · high grade malignant neoplasm · leukemia · major salivary gland carcinoma · malignant pancreatic neoplasm · myelodysplastic syndrome · osteosarcoma · ovarian cancer · ovarian carcinoma · pancreatic exocrine neoplasm · primary peritoneal carcinoma · prolymphocytic leukemia · prostate cancer · serous adenocarcinoma · urothelial carcinoma · uterine corpus cancer · breast carcinoma
Investigated by
AstraZeneca · National Cancer Institute (NCI) · Cancer Research UK · Institute of Cancer Research, United Kingdom · Parexel · Samsung Medical Center
+42 more · Acerta Pharma BV · Dana-Farber Cancer Institute · M.D. Anderson Cancer Center · Royal Marsden NHS Foundation Trust · Seoul National University Hospital · Assistance Publique Hopitaux De Marseille · Beatson West of Scotland Cancer Centre · CCTU- Cancer Theme · CLL Consortium · Experimental Cancer Medicine Centres · Fight Kids Cancer · Fondation ARC · Gordon Mills, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris · IFOM ETS - The AIRC Institute of Molecular Oncology · Joseph Paul Eder · Mario Negri Institute for Pharmacological Research · Massachusetts General Hospital · Mirati Therapeutics Inc. · National Cancer Institute, France · Newcastle University · Oregon Health and Science University · Osteosarcoma Institute · Pfizer · Queen's University, Belfast · RM/ICR Biomedical Research Centre · Rahul Aggarwal · SWOG Cancer Research Network · Se-Hoon Lee · The Cleveland Clinic · The Leeds Teaching Hospitals NHS Trust · University College London Hospitals · University of Birmingham · University of Glasgow · University of Leeds · University of Manchester · University of Michigan Rogel Cancer Center · University of Oxford · University of Pennsylvania · University of Sheffield · Vanderbilt-Ingram Cancer Center · Velindre NHS Trust

Trials 46

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 115 trials
Phase 1 NCT06754761 Sep → Oct 2025 neoplasm AstraZeneca Terminated No outcome recorded Stop: Business
Phase 1 NCT06929260 May → Oct 2025 neoplasm AstraZeneca Terminated No outcome recorded
Phase 1 NCT05514132 Sep 2022 → Oct 2023 overdue cancer AstraZeneca Active not recruiting No outcome recorded
Phase 1 NCT05469919 Jun 2022 → Aug 2023 — AstraZeneca Completed No outcome recorded
Phase 1 NCT04704661 Aug 2021 → Mar 2027 expected HER2 positive breast carcinoma, colon carcinoma, endometrial carcinoma, female breast carcinoma +6 National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1 NCT04550104 Mar 2021 → Mar 2026 overdue non-small cell lung carcinoma University of Leeds Recruiting No outcome recorded
Phase 1 NCT03669601 Oct 2019 → Sep 2023 cancer CCTU- Cancer Theme Unknown No outcome recorded
Phase 1 NCT03770429 Aug 2019 → Apr 2025 overdue leukemia, myelodysplastic syndrome Massachusetts General Hospital Active not recruiting No outcome recorded
Phase 1 NCT03527147 Jun 2018 → Mar 2021 diffuse large B-cell lymphoma Acerta Pharma BV Completed No outcome recorded
Phase 1 NCT03328273 Jan 2018 → Sep 2021 overdue B-cell chronic lymphocytic leukemia Acerta Pharma BV Active not recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02813135 Aug 2016 → Feb 2031 expected childhood malignant neoplasm Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
Phase 228 trials
Phase 2 NCT06769126 Nov 2025 → Dec 2028 expected small cell lung carcinoma SWOG Cancer Research Network Recruiting No outcome recorded
Phase 2 NCT06680050 Aug 2025 → Jun 2028 expected non-small cell lung carcinoma Mario Negri Institute for Pharmacological Research Recruiting No outcome recorded
Phase 2 NCT05941897 Jun 2023 → Jul 2024 overdue non-small cell lung carcinoma AstraZeneca Active not recruiting No outcome recorded
Phase 2 NCT05582538 Dec 2022 → Dec 2027 expected triple-negative breast carcinoma IFOM ETS - The AIRC Institute of Molecular Oncology Recruiting No outcome recorded
Phase 2 NCT05061134 Aug 2022 → Apr 2024 overdue melanoma AstraZeneca Active not recruiting No outcome recorded
Phase 2 NCT04564027 Dec 2020 → Feb 2025 cancer AstraZeneca Completed No outcome recorded
Phase 2 NCT04417062 Nov 2020 → Jun 2025 overdue osteosarcoma Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 2 NCT04239014 Aug 2020 → Jan 2021 ovarian cancer AstraZeneca Withdrawn No outcome recorded
Phase 2 NCT04090567 Jul 2020 → Dec 2027 expected BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT04298008 Jun 2020 → Dec 2024 bile duct cancer, chemotherapy-induced toxicity Seoul National University Hospital Unknown No outcome recorded
Phase 32 trials · 1 missed
Phase 3 NCT06732401 Aug 2025 → Jun 2028 expected non-small cell lung carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 3 NCT05450692 Sep 2022 → Oct 2025 overdue non-small cell lung carcinoma AstraZeneca Active not recruiting Missed primary
Comparator or background therapy2 trials
Phase 2 NCT04699838 Background Apr 2021 → Jan 2027 expected small cell lung carcinoma Muhammad Furqan Active not recruiting No outcome recorded
Phase 2 NCT03330847 Comparator Mar 2018 → Nov 2020 overdue triple-negative breast carcinoma AstraZeneca Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2025-12-22 AstraZeneca Results Update on LATIFY Phase III trial of ceralasertib plus Imfinzi in previously treated advanced non-small cell lung cancer astrazeneca.com ↗
The LATIFY Phase III trial of ceralasertib in combination with Imfinzi (durvalumab) did not meet the primary endpoint of overall survival (OS) versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
2021-05-19 AstraZeneca Results AstraZeneca ASCO 2021 data support ambition to revolutionise cancer outcomes by treating earlier and transforming the patient experience astrazeneca.com ↗
showing that this combination demonstrated promising anti-tumour activity in melanoma patients for whom prior anti-PD1 treatment had failed.
2018-04-04 AstraZeneca Results AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC astrazeneca.com ↗
The PARP inhibitor olaparib is synergistic with the ATR inhibitor AZD6738 in ATM deficient cancer cells
2017-03-28 AstraZeneca Results Astrazeneca to share its robust early science in oncology with the medical community at AACR 2017 astrazeneca.com ↗
Preclinical data uncovering a novel role for the bromodomain protein, BRD4, in regulating DNA replication-stress response, and the potential of the combination of the BRD4 inhibitor, AZD5153, and the ATR inhibitor, AZD6738, in the sustained delay of tumour growth (Abstract #1026)

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 52 sources stand behind the page.

FieldValueCited text
Known as ceralasertib “Phase 1 study of ATRinhibition alone or with radiation therapy (PATRIOT) was a first-in-human phase I study of the oral ATR (ataxia telangiectasia and Rad3-related) inhibitor...” PMID 37934611 ↗ Jan 2024
31

“Ceralasertib (AZD6738) is an oral kinase inhibitor of ataxia telangiectasia and Rad3 related protein, which is a master regulator of DDR.” PMID 35790315 ↗ Jul 2022

“Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase ATR” NCT06754761 ↗

NCT03579316 ↗

NCT02813135 ↗

NCT06680050 ↗

NCT06929260 ↗

NCT04065269 ↗

NCT04090567 ↗

NCT05061134 ↗

NCT03330847 ↗

Show 21 more sources

Known as Atr kinase inhibitor azd6738 ChEMBL registry synonym — accepted as the source's own label CHEMBL4285417 ↗
Known as AZD6738 “Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase, ATR, with good selectivity against other phosphatidylinositol...” NCT05514132 ↗
24

“Durvalumab 1500mg via IV administered for every 4weeks(fixed dosing for subjects \> 30 kg body weight) in Day 1 of each cycle and AZD 6738 240mg bid per os administered in each...” NCT04361825 ↗

“Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase ATR” NCT06754761 ↗

“Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects” NCT04361825 ↗

“Study Evaluating Radiotherapy Followed by Durvalumab (MEDI4736) and Ceralasertib (AZD6738)” PMID 40781023 ↗ Jul 2025

“AZD6738 240 mg bid on D15-D28 Every 4 weeks” NCT04298021 ↗

“Ceralasertib \[AZD6738\]” NCT03330847 ↗

“Ceralasertib (AZD6738)” NCT04699838 ↗

“Ceralasertib (AZD6738)” NCT03833440 ↗

NCT03669601 ↗

NCT01955668 ↗

Show 14 more sources

Action Inhibit “oral ATR (ataxia telangiectasia and Rad3-related) inhibitor” PMID 37934611 ↗ Jan 2024
Modality Small molecule — CHEMBL4285417 ↗
Route Oral “given orally” NCT01955668 ↗
Target ATR “oral ATR (ataxia telangiectasia and Rad3-related) inhibitor ceralasertib (AZD6738)” PMID 37934611 ↗ Jan 2024