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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 18 indications[3], with its most advanced program in Phase 3.[1]

Ceralasertib is one of 327 small molecule programs targeting Lung Non-Small Cell Carcinoma. It is currently in Phase 3.

18

Indications

28

Total Trials

22

Active Trials

326

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lung Non-Small Cell CarcinomaActive, not recruiting

Pediatric CancerRecruiting

Extensive-Stage Small-Cell Lung CancerActive, not recruiting

Advanced or Metastatic Non-Small Cell Lung CancerActive, not recruiting

Recurrent Fallopian Tube CarcinomaActive, not recruiting

Advanced Solid TumoursTerminated

Malignant Solid NeoplasmActive, not recruiting

Advanced Breast CarcinomaActive, not recruiting

Gynaecological CancersActive, not recruiting

Phase IIActive, not recruiting

Lung Non-Small Cell CarcinomaPhase 3

Active, not recruiting

Pediatric CancerPreclinical

Recruiting

Extensive-Stage Small-Cell Lung CancerPhase 2

Active, not recruiting

Advanced or Metastatic Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Recurrent Fallopian Tube CarcinomaPhase 2

Active, not recruiting

Advanced Solid TumoursPhase 1

Terminated

Malignant Solid NeoplasmPhase 2

Active, not recruiting

Advanced Breast CarcinomaPhase 1

Active, not recruiting

Gynaecological CancersPhase 2

Active, not recruiting

Phase IIPhase 2

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ceralasertib

Adenocard

Blenoxane

Bristol-Myers Squibb

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Tianeptine

Metfomin

UUniversity of Texas Southwestern Medical Center

Diuretic

RReprieve Cardiovascular, Inc

Recombinant Human Endostatin

PPeking University Third Hospital

Bisphosphonate

Motexafin Gadolinium

PPharmacyclics LLC.

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Triple-Negative Breast Cancer

NCT03330847

Phase 2Active, not recruiting

Melanoma

NCT05061134

Phase 2Active, not recruiting

Osteosarcoma

NCT04417062

Phase 2Active, not recruiting

Recurrent Fallopian Tube Carcinoma

NCT03579316

Q1 2027

Phase 2Active, not recruiting

Advanced or Metastatic NSCLC

NCT05941897

Phase 1Active, not recruiting

Advanced Breast Carcinoma

NCT04704661

Clinical

Trials by Indication[1]

Advanced Breast Carcinoma2 trials

Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced Breast Cancer

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

Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH Trial)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04704661·51 enrolled

Advanced Solid Tumours2 trials

A Phase I, Multi-centre, Open-label, Dose Exploration Study to Assess the Safety and Tolerability of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT05514132·14 enrolled

A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT06929260·1 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

Breast Cancer1 trial

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

21 more indications

Non-Small Cell Lung Cancer1 trial

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

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

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

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

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

Radiotherapy1 trial

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

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

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

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

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

Advanced or Metastatic NSCLC1 trial

A Phase II, Open-label, Multicentre, Non-comparative, Single-arm Local Study of Ceralasertib Plus Durvalumab 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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05941897·39 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

Osteosarcoma1 trial

Phase II Trial of Olaparib in Combination With Ceralasertib in Patients With Recurrent Osteosarcoma

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT04417062·49 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

Malignant Solid Neoplasm1 trial

A Phase II Study of Olaparib and AZD6738 in Isocitrate Dehydrogenase (IDH) Mutant Solid Tumors

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

Recurrent Fallopian Tube Carcinoma1 trial

EFFORT: Efficacy of AZD1775 in Parp Resistance; A Randomized 2-Arm, Non-Comparative Phase 2 Study of AZD1775 Alone or AZD1775 and Olaparib in Women With Ovarian Cancer Who Have Progressed During PARP Inhibition

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

Chronic Lymphocytic Leukemia1 trial

A Phase 1 Proof-of-Concept Study Investigating AZD6738 Monotherapy and Acalabrutinib in Combination With AZD6738 (ATR Inhibitor) in Subjects With Relapsed or Refractory High-risk Chronic Lymphocytic Leukemia (CLL)

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

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

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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