Ceralasertib (AZD6738) is currently being evaluated across numerous clinical trials spanning early to late phases for advanced solid tumors, non-small cell lung cancer, small cell lung carcinoma, melanoma, and gynecological cancers. Supported by industry sponsors such as AstraZeneca alongside academic networks including the National Cancer Institute, these studies comprise recruiting, active not recruiting, completed, and terminated recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02813135 | RECRUITING | Pediatric Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2016-08-03 | PHASE1; PHASE2 |
| NCT06769126 | RECRUITING | Extensive Stage Lung Small Cell Carcinoma; Lung Small Cell Carcinoma, A Subtype; Lung Small Cell Carcinoma, I Subtype; Lung Small Cell Carcinoma, N Subtype; Lung Small Cell Carcinoma, P Subtype |
SWOG Cancer Research Network |
2025-11-06 | PHASE2 |
| NCT06732401 | ACTIVE_NOT_RECRUITING | Lung Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2025-08-07 | PHASE3 |
| NCT06680050 | RECRUITING | Non Small Cell Lung Cancer NSCLC |
Mario Negri Institute for Pharmacological Research |
2025-08-07 | PHASE2 |
| NCT03682289 | ACTIVE_NOT_RECRUITING | Clear Cell Renal Cell Carcinoma; Locally Advanced Pancreatic Cancer; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Metastatic Renal Cell Carcinoma; Metastatic Urothelial Carcinoma; Metastatic Pancreatic Cancer; Stage III Pancreatic Cancer; Stage III Renal Cell Cancer; Stage IV Pancreatic Cancer; Stage IV Renal Cell Cancer; Endometrial Cancer; Metastatic Castration-resistant Prostate Cancer |
Rahul Aggarwal |
2019-01-17 | PHASE2 |
| NCT04090567 | RECRUITING | Advanced Breast Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation; HER2/Neu Negative; Metastatic Breast Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2020-07-28 | PHASE2 |
| NCT05582538 | RECRUITING | Triple Negative Breast Cancer Metastatic |
IFOM ETS - The AIRC Institute of Molecular Oncology |
2022-12-15 | PHASE2 |
| NCT04704661 | ACTIVE_NOT_RECRUITING | Advanced Breast Carcinoma; Advanced Colon Carcinoma; Advanced Colorectal Carcinoma; Advanced Endometrial Carcinoma; Advanced Gastric Carcinoma; Advanced Gastroesophageal Junction Adenocarcinoma; Advanced Malignant Solid Neoplasm; Advanced Salivary Gland Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; HER2-Positive Breast Carcinoma; Malignant Hepatobiliary Neoplasm; Metastatic Breast Carcinoma; Metastatic Colon Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Endometrial Carcinoma; Metastatic Gastric Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Salivary Gland Carcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Major Salivary Gland Cancer AJCC v8; Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Major Salivary Gland Cancer AJCC v8; Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Unresectable Breast Carcinoma; Unresectable Colon Carcinoma; Unresectable Colorectal Carcinoma; Unresectable Endometrial Carcinoma; Unresectable Gastric Carcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Salivary Gland Carcinoma |
National Cancer Institute (NCI) |
2021-08-09 | PHASE1 |
| NCT04699838 | ACTIVE_NOT_RECRUITING | Extensive Stage Small Cell Lung Cancer |
Muhammad Furqan |
2021-04-20 | PHASE2 |
| NCT03579316 | ACTIVE_NOT_RECRUITING | Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma |
M.D. Anderson Cancer Center |
2018-12-07 | PHASE2 |
| NCT03740893 | RECRUITING | Breast Neoplasm; Triple Negative Breast Cancer (TNBC); HRD |
Institute of Cancer Research, United Kingdom |
2019-10-15 | PHASE2 |
| NCT04065269 | ACTIVE_NOT_RECRUITING | Gynaecological Cancers |
Institute of Cancer Research, United Kingdom |
2019-11-27 | PHASE2 |
| NCT04550104 | RECRUITING | Non Small Cell Lung Cancer |
University of Leeds |
2021-03-17 | PHASE1 |
| NCT02223923 | UNKNOWN | Solid Tumour Refractory to Conventional Treatment |
Royal Marsden NHS Foundation Trust |
2014-07 | PHASE1 |
| NCT06754761 | TERMINATED | Neoplasm |
AstraZeneca |
2025-09-22 | PHASE1 |
| NCT06929260 | TERMINATED | Advanced Solid Tumours |
AstraZeneca |
2025-05-21 | PHASE1 |
| NCT05450692 | ACTIVE_NOT_RECRUITING | Advanced or Metastatic Non-Small Cell Lung Cancer |
AstraZeneca |
2022-09-15 | PHASE3 |
| NCT03462342 | COMPLETED | High Grade Serous Carcinoma |
University of Pennsylvania |
2018-03-09 | PHASE2 |
| NCT04417062 | ACTIVE_NOT_RECRUITING | Osteosarcoma; Osteosarcoma Recurrent |
Dana-Farber Cancer Institute |
2020-11-24 | PHASE2 |
| NCT03770429 | ACTIVE_NOT_RECRUITING | Leukemia; Myelodysplastic Syndrome |
Massachusetts General Hospital |
2019-08-05 | PHASE1 |
| NCT03878095 | ACTIVE_NOT_RECRUITING | Malignant Solid Neoplasm; Refractory Cholangiocarcinoma; Refractory Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2020-01-30 | PHASE2 |
| NCT02264678 | ACTIVE_NOT_RECRUITING | Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer |
AstraZeneca |
2014-10-31 | PHASE1 |
| NCT04564027 | COMPLETED | Advanced Solid Tumours |
AstraZeneca |
2020-12-01 | PHASE2 |
| NCT04298021 | UNKNOWN | Bile Duct Cancer; Chemotherapy Effect |
Seoul National University Hospital |
2020-06-25 | PHASE2 |
| NCT04298008 | UNKNOWN | Bile Duct Cancer; Chemotherapy Effect |
Seoul National University Hospital |
2020-06-25 | PHASE2 |
| NCT03801369 | TERMINATED | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma |
Gordon Mills, MD, PhD |
2018-12-12 | PHASE2 |
| NCT03833440 | UNKNOWN | Non-small Cell Lung Cancer |
Assistance Publique Hopitaux De Marseille |
2019-10-08 | PHASE2 |
| NCT03334617 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer |
AstraZeneca |
2017-12-18 | PHASE2 |
| NCT05941897 | ACTIVE_NOT_RECRUITING | Advanced or Metastatic NSCLC |
AstraZeneca |
2023-06-21 | PHASE2 |
| NCT05061134 | ACTIVE_NOT_RECRUITING | Melanoma |
AstraZeneca |
2022-08-11 | PHASE2 |
| NCT02664935 | COMPLETED | Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma |
University of Birmingham |
2015-05-13 | PHASE2 |
| NCT04361825 | COMPLETED | Small Cell Lung Cancer |
Se-Hoon Lee |
2020-06-17 | PHASE2 |
| NCT05514132 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumours |
AstraZeneca |
2022-09-23 | PHASE1 |
| NCT03669601 | UNKNOWN | Cancer |
CCTU- Cancer Theme |
2019-10-15 | PHASE1 |
| NCT05469919 | COMPLETED | Advanced Solid Malignancies |
AstraZeneca |
2022-06-09 | PHASE1 |
| NCT05941897 | Active not recruiting | Advanced or Metastatic NSCLC |
AstraZeneca |
2023-06-21 | Phase 2 |
| NCT03787680 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
University of Michigan Rogel Cancer Center |
2019-10-31 | PHASE2 |
| NCT03780608 | UNKNOWN | Gastric Adenocarcinoma; Malignant Melanoma |
Samsung Medical Center |
2019-07-30 | PHASE2 |
| NCT03182634 | UNKNOWN | Advanced Breast Cancer |
Institute of Cancer Research, United Kingdom |
2016-12-15 | PHASE2 |
| NCT05514132 | Active not recruiting | Advanced Solid Tumours |
AstraZeneca |
2022-09-23 | Phase 1 |
| NCT05450692 | Recruiting | Advanced or Metastatic Non-Small Cell Lung Cancer |
AstraZeneca|Parexel |
2022-09-15 | Phase 3 |
| NCT05061134 | Active not recruiting | Melanoma |
AstraZeneca |
2022-08-11 | Phase 2 |
| NCT05469919 | Active not recruiting | Advanced Solid Malignancies |
AstraZeneca |
2022-06-09 | Phase 1 |
| NCT03328273 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2018-01-31 | PHASE1 |
| NCT04704661 | Recruiting | Advanced Breast Carcinoma|Advanced Colon Carcinoma|Advanced Colorectal Carcinoma|Advanced Endometrial Carcinoma|Advanced Gastric Carcinoma|Advanced Gastroesophageal Junction Adenocarcinoma|Advanced Malignant Solid Neoplasm|Advanced Salivary Gland Carcinoma|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IIIA Breast Cancer AJCC v8|Anatomic Stage IIIB Breast Cancer AJCC v8|Anatomic Stage IIIC Breast Cancer AJCC v8|Anatomic Stage IV Breast Cancer AJCC v8|Clinical Stage III Gastric Cancer AJCC v8|Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8|Clinical Stage IV Gastric Cancer AJCC v8|Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8|Clinical Stage IVA Gastric Cancer AJCC v8|Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8|Clinical Stage IVB Gastric Cancer AJCC v8|Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8|HER2-Positive Breast Carcinoma|Malignant Hepatobiliary Neoplasm|Metastatic Breast Carcinoma|Metastatic Gastroesophageal Junction Adenocarcinoma|Metastatic Malignant Solid Neoplasm|Pathologic Stage III Gastric Cancer AJCC v8|Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8|Pathologic Stage IIIA Gastric Cancer AJCC v8|Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8|Pathologic Stage IIIB Gastric Cancer AJCC v8|Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8|Pathologic Stage IIIC Gastric Cancer AJCC v8|Pathologic Stage IV Gastric Cancer AJCC v8|Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8|Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8|Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8|Prognostic Stage III Breast Cancer AJCC v8|Prognostic Stage IIIA Breast Cancer AJCC v8|Prognostic Stage IIIB Breast Cancer AJCC v8|Prognostic Stage IIIC Breast Cancer AJCC v8|Prognostic Stage IV Breast Cancer AJCC v8|Stage III Colon Cancer AJCC v8|Stage III Colorectal Cancer AJCC v8|Stage III Major Salivary Gland Cancer AJCC v8|Stage III Uterine Corpus Cancer AJCC v8|Stage IIIA Colon Cancer AJCC v8|Stage IIIA Colorectal Cancer AJCC v8|Stage IIIA Uterine Corpus Cancer AJCC v8|Stage IIIB Colon Cancer AJCC v8|Stage IIIB Colorectal Cancer AJCC v8|Stage IIIB Uterine Corpus Cancer AJCC v8|Stage IIIC Colon Cancer AJCC v8|Stage IIIC Colorectal Cancer AJCC v8|Stage IIIC Uterine Corpus Cancer AJCC v8|Stage IIIC1 Uterine Corpus Cancer AJCC v8|Stage IIIC2 Uterine Corpus Cancer AJCC v8|Stage IV Colon Cancer AJCC v8|Stage IV Colorectal Cancer AJCC v8|Stage IV Major Salivary Gland Cancer AJCC v8|Stage IV Uterine Corpus Cancer AJCC v8|Stage IVA Colon Cancer AJCC v8|Stage IVA Colorectal Cancer AJCC v8|Stage IVA Major Salivary Gland Cancer AJCC v8|Stage IVA Uterine Corpus Cancer AJCC v8|Stage IVB Colon Cancer AJCC v8|Stage IVB Colorectal Cancer AJCC v8|Stage IVB Major Salivary Gland Cancer AJCC v8|Stage IVB Uterine Corpus Cancer AJCC v8|Stage IVC Colon Cancer AJCC v8|Stage IVC Colorectal Cancer AJCC v8|Stage IVC Major Salivary Gland Cancer AJCC v8|Unresectable Colorectal Carcinoma|Unresectable Gastroesophageal Junction Adenocarcinoma|Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2021-08-09 | Phase 1 |
| NCT03527147 | COMPLETED | NHL; DLBCL; Non-hodgkin's Lymphoma; Diffuse Large B Cell Lymphoma |
Acerta Pharma BV |
2018-06-19 | PHASE1 |
| NCT04239014 | WITHDRAWN | Ovarian Cancer |
AstraZeneca |
2020-08-07 | PHASE2 |
| NCT03022409 | COMPLETED | Head and Neck Squamous Cell Carcinoma |
AstraZeneca |
2017-09-18 | PHASE1 |
| NCT03428607 | COMPLETED | SCLC |
Samsung Medical Center |
2018-10-17 | PHASE2 |
| NCT02630199 | COMPLETED | Refractory Cancer |
Samsung Medical Center |
2015-12 | PHASE1 |
| NCT03330847 | ACTIVE_NOT_RECRUITING | Metastatic Triple Negative Breast Cancer |
AstraZeneca |
2018-03-07 | PHASE2 |
| NCT02937818 | COMPLETED | Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma |
AstraZeneca |
2016-11-28 | PHASE2 |
| NCT02576444 | TERMINATED | Cancer |
Joseph Paul Eder |
2015-11 | PHASE2 |
| NCT01955668 | COMPLETED | 11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL),; Prolymphocytic Leukaemia (PLL); B Cell Lymphomas |
AstraZeneca |
2013-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-10)
Check the
Ceralasertib (AZD6738)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Ceralasertib (AZD6738) Mechanism of Action: ATR Inhibition in T Cell Research
- Ceralasertib (AZD6738): Selectivity & Specificity
- Ceralasertib (AZD6738) Working Concentration | Cell Culture | Treatment
- Ceralasertib (AZD6738) Solubility in DMSO
- Ceralasertib (AZD6738) Stock Solution
- Ceralasertib (AZD6738) Storage
- Ceralasertib (AZD6738) Stability
- Ceralasertib (AZD6738) Combination Database
- Ceralasertib (AZD6738) Molecular Weight
- Ceralasertib (AZD6738) SMILES
- Ceralasertib (AZD6738) CAS Number
- Ceralasertib (AZD6738) Chemical Structure (2D and 3D)
- Ceralasertib (AZD6738) IC50 for Cell-based and Cell-free Assays
- Ceralasertib (AZD6738) MedChemExpress (HY-19323)? Try a better option.
- Ceralasertib (AZD6738) Abmole (M8914)? Try a better option.
- Ceralasertib (AZD6738) Cayman (21035)? Try a better option.
- Ceralasertib (AZD6738) Sigma (AMBH2D6FF0A7)? Try a better option.
- Ceralasertib (AZD6738) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.