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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 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... |
| 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... |
| 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... |
| 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... |
| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | HUN | GBR | FRA | ESP | CAN | BEL | AUS | 1 |
| 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 | POL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 1 |
| NCT04564027 | Phase II | Ceralasertib | A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer | Active, not recruiting | USA | FRA | ESP | 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 |
| 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) | Recruiting | GBR | CAN | 0 |
| NCT03770429 | Phase I | Ceralasertib | AZD6738 for Patients With Progressive MDS or CMML | Recruiting | USA | 0 |
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