Therapy Detail

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Therapy Name Ceralasertib
Synonyms
Therapy Description

Ceralasertib (AZD6738) is an inhibitor of ATR, which may enhance the sensitivity of chemotherapeutic agents, potentially resulting in tumor regression (PMID: 26517239, PMID: 31836456).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ceralasertib AZD6738|AZD-6738 ATR Inhibitor 16 Ceralasertib (AZD6738) is an inhibitor of ATR, which may enhance the sensitivity of chemotherapeutic agents, potentially resulting in tumor regression (PMID: 26517239, PMID: 31836456).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ATR over exp chronic lymphocytic leukemia predicted - sensitive Ceralasertib Preclinical Actionable In a preclinical study, chronic lymphocytic leukemia cells expressing ATR were sensitive to AZD6738 (Cancer Res October 1, 2014 74; 5485). detail...
ATM inact mut prostate cancer no benefit Ceralasertib Phase II Actionable In a Phase IIa trial (PLANETTE), Ceralasertib (AZD6738) treatment demonstrated manageable safety but limited efficacy in patients with metastatic castration-resistant prostate cancer harboring ATM mutations and/or ATM loss (n=15), with a composite response rate of 7.7% (1/13) in patients with confirmed ATM mutations (Cancer Res (2024) 84 (7_Supplement): CT222; NCT04564027). detail...
FBXW7 del Advanced Solid Tumor sensitive Ceralasertib Preclinical - Cell culture Actionable In a preclinical study, a cell line with knockout of FBXW7 demonstrated increased sensitivity to Ceralasertib (AZD6738) treatment compared to cells with wild-type FBXW7 in culture (PMID: 38032106). 38032106
ATM inact mut Advanced Solid Tumor no benefit Ceralasertib Phase II Actionable In a Phase IIa trial (PLANETTE), Ceralasertib (AZD6738) treatment demonstrated manageable safety but limited efficacy in patients with advanced solid tumors excluding non-small cell lung cancer harboring ATM mutations and/or loss of ATM protein expression (n=30), resulting in an objective response rate of 7.1% (2/28, 1 complete and 1 partial response) (Cancer Res (2024) 84 (7_Supplement): CT222; NCT04564027). detail...
IDH1 R132H Advanced Solid Tumor sensitive Ceralasertib Preclinical - Cell culture Actionable In a preclinical study, treatment with Ceralasertib (AZD6738) resulted in decreased survival in cell lines expressing IDH1 R132H in culture (PMID: 34027408). 34027408
ATM negative prostate cancer no benefit Ceralasertib Phase II Actionable In a Phase IIa trial (PLANETTE), Ceralasertib (AZD6738) treatment demonstrated manageable safety but limited efficacy in patients with metastatic castration-resistant prostate cancer harboring ATM mutations and/or loss of ATM protein expression (n=15), resulting in a composite response rate of 7.7% (1/13) (Cancer Res (2024) 84 (7_Supplement): CT222; NCT04564027). detail...
FBXW7 R465H cervical cancer sensitive Ceralasertib Preclinical - Cell culture Actionable In a preclinical study, a cervical cancer cell line harboring FBXW7 R465H demonstrated increased sensitivity to Ceralasertib (AZD6738) treatment compared to cell lines with wild-type FBXW7 in culture (PMID: 38032106). 38032106
FBXW7 del cervical cancer sensitive Ceralasertib Preclinical - Cell culture Actionable In a preclinical study, an organoid cell line generated from patient-derived xenograft tissue of cervical cancer with knockout of FBXW7 demonstrated increased sensitivity to Ceralasertib (AZD6738) treatment compared to the parental organoid cell line with wild-type FBXW7 in culture (PMID: 38032106). 38032106
ATM negative Advanced Solid Tumor no benefit Ceralasertib Phase II Actionable In a Phase IIa trial (PLANETTE), Ceralasertib (AZD6738) treatment demonstrated manageable safety but limited efficacy in patients with advanced solid tumors excluding non-small cell lung cancer harboring ATM mutations and/or loss of ATM protein expression (n=30), resulting in an objective response rate of 7.1% (2/28, 1 complete and 1 partial response) (Cancer Res (2024) 84 (7_Supplement): CT222; NCT04564027). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03801369 Phase II Durvalumab + Olaparib Ceralasertib Olaparib + Selumetinib Capivasertib + Olaparib Olaparib in Combination With Either Durvalumab, Selumetinib, or Capivasertib or Ceralasertib Alone in Treating Patients With Metastatic Triple Negative Breast Cancer Recruiting USA 0
NCT05061134 Phase II Ceralasertib + Durvalumab Ceralasertib A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition (MONETTE) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 2
NCT03022409 Phase I Olaparib Ceralasertib 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 USA | FRA 1
NCT04065269 Phase II Ceralasertib + Olaparib Ceralasertib ATr Inhibitor in Combination With Olaparib in Gynaecological Cancers With ARId1A Loss or no Loss (ATARI) Unknown status GBR 0
NCT03740893 Phase II Olaparib Ceralasertib Durvalumab PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer (PHOENIX) Recruiting GBR 0
NCT02264678 Phase Ib/II Ceralasertib Carboplatin + Ceralasertib Ceralasertib + Durvalumab Ceralasertib + Olaparib Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents Recruiting USA | GBR | FRA | ESP | CAN | BEL | AUS 2
NCT03770429 Phase I Ceralasertib AZD6738 for Patients With Progressive MDS or CMML Recruiting USA 0
NCT04564027 Phase II Ceralasertib A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer Active, not recruiting USA | FRA | ESP 0


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