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Ceralasertib

Phase 3Small molecule

Ceralasertib is an experimental drug being tested to treat certain cancers by blocking a protein that helps cancer cells survive and repair themselves.[1] Ceralasertib is currently being investigated across 15 indications[3], with its most advanced program in Phase 3.[1]

Ceralasertib is one of 369 small molecule programs targeting Osteosarcoma. It is currently in Phase 3.

15

Indications

28

Total Trials

22

Active Trials

368

Competitors

Pipeline

Status by Indication[3][1]

Indication

OsteosarcomaActive, not recruiting

Fallopian Tube CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

Prostate CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaActive, not recruiting

CholangiocarcinomaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

OsteosarcomaPhase 2

Active, not recruiting

Fallopian Tube CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

MelanomaPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 1

Active, not recruiting

CholangiocarcinomaPhase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 1

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ceralasertib

Adriamycin

GGynecologic Oncology Group

Prolia

Gemzar

GGynecologic Oncology Group

Cymbalta

Alnylam Pharmaceuticals

Zolymbus

Acupan

YYonsei University

Paracetamol

Neoadjuvant Therapy

SSun Yat-sen University

Recombinant Human Chorionic Gonadotropin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Gynaecological Cancers

NCT04065269

Phase 1Active, not recruiting

Chronic Lymphocytic Leukemia

NCT03328273

Phase 2Active, not recruiting

Phase II

NCT03334617

Q4 2026

Phase 2Active, not recruiting

Triple-Negative Breast Cancer

NCT03330847

Phase 2Active, not recruiting

Extensive-Stage Small-Cell Lung Cancer

NCT04699838

Phase 2Active, not recruiting

Melanoma

NCT05061134

Clinical

Trials by Indication[1]

Breast Cancer2 trials

Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04090567·60 enrolled

Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel

Recruiting·IIFOM ETS - The AIRC Institute of Molecular Oncology·Phase 2·NCT05582538·37 enrolled

Non-Small Cell Lung Cancer2 trials

A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05941897·39 enrolled

Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance

Active, not recruiting·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT03833440·114 enrolled

Small Cell Lung Cancer1 trial

Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT06769126·900 enrolled

Advanced Solid Malignancies1 trial

An Open-Label Phase 1 Study of Ceralasertib in Japanese Patients With Advanced Solid Malignancies

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05469919·12 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03022409·21 enrolled

21 more indications

Gynaecological Cancers1 trial

ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss

Active, not recruiting·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT04065269·174 enrolled

Osteosarcoma1 trial

Olaparib With Ceralasertib in Recurrent Osteosarcoma

Active, not recruiting·—·Phase 2·NCT04417062·63 enrolled

Patients With Solid Tumors1 trial

Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors

Recruiting·RRahul Aggarwal·Phase 2·NCT03682289·89 enrolled

Tumors1 trial

Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03878095·24 enrolled

Phase 21 trial

AMTEC IIT: Phase 2 Multiarm Study in TNBC

Terminated·—·Phase 2·NCT03801369·24 enrolled

Advanced Cancer1 trial

A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04564027·54 enrolled

Advanced Solid Tumours1 trial

A Study to Evaluate the Safety and Pharmacokinetics of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT05514132·14 enrolled

Oligometastases1 trial

Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen

Recruiting· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT06680050·21 enrolled

Chronic Lymphocytic Leukemia1 trial

A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Active, not recruiting·AAcerta Pharma BV·Phase 1·NCT03328273·12 enrolled

Phase II1 trial

Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03334617·528 enrolled

Radiotherapy1 trial

A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC

Recruiting·UUniversity of Leeds·Phase 1·NCT04550104·200 enrolled

Melanoma1 trial

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05061134·194 enrolled

Drug1 trial

A Study to Evaluate the Effect of Ceralasertib on Drug X, Drug Y and Drug Z

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT06929260·1 enrolled

Ovarian Cancer1 trial

A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment.

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT04239014

Fallopian Tube Cancer1 trial

Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03579316·96 enrolled

Advanced Solid Tumors1 trial

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04704661·51 enrolled

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05450692·594 enrolled

Extensive-stage Small-cell Lung Cancer1 trial

A Phase II Study of Chemo-Immunotherapy Followed by Durvalumab (MEDI4736) and Ceralasertib (AZD6738) in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Big Ten Cancer Research Consortium BTCRC-LUN18-363

Active, not recruiting·MMuhammad Furqan·Phase 2·NCT04699838·30 enrolled

Pediatric Cancer1 trial

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Triple-Negative Breast Cancer1 trial

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03330847·273 enrolled

Lung Non-Small Cell Carcinoma1 trial

A Randomized Phase III Trial of Checkpoint Blockade in Lung Cancer Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (CLEAR)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06732401·630 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Ceralasertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ceralasertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ceralasertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serine-Protein Kinase ATR Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

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