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Therapy Name	ALRN-6924
Synonyms
Therapy Description	ALRN-6924 (CS-0044703) binds to MDM2 and MDM4 (MDMX) and prevents their interaction with p53, resulting in restoration of p53 activity and potentially leading to increased tumor cell death (PMID: 29643228, PMID: 30253242).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
ALRN-6924		CS-0044703	MDM2 Inhibitor 23 MDM4 inhibitor 8	ALRN-6924 (CS-0044703) binds to MDM2 and MDM4 (MDMX) and prevents their interaction with p53, resulting in restoration of p53 activity and potentially leading to increased tumor cell death (PMID: 29643228, PMID: 30253242).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
TP53 wild-type	Advanced Solid Tumor	predicted - sensitive	ALRN-6924	Phase I	Actionable	In a Phase I trial, treatment with ALRN-6924 in patients with advanced solid tumors and lymphomas resulted in a disease control rate of 59% (24/41), with 2 patients experiencing a complete response, 2 patients achieving a partial response, and 20 patients demonstrating stable disease (PMID: 34301750; NCT02264613).	34301750
TP53 wild-type	lymphoma	predicted - sensitive	ALRN-6924	Phase I	Actionable	In a Phase I trial, treatment with ALRN-6924 in patients with advanced solid tumors and lymphomas resulted in a disease control rate of 59% (24/41), with 2 patients experiencing a complete response, 2 patients achieving a partial response, and 20 patients demonstrating stable disease (PMID: 34301750; NCT02264613).	34301750
TP53 wild-type	liposarcoma	predicted - sensitive	ALRN-6924	Case Reports/Case Series	Actionable	In a Phase I trial, ALRN-6924 treatment resulted in a partial response in a patient with liposarcoma (PMID: 34301750; NCT02264613).	34301750
TP53 wild-type	Merkel cell carcinoma	predicted - sensitive	ALRN-6924	Case Reports/Case Series	Actionable	In a Phase I trial, ALRN-6924 treatment in a patient with Merkel cell carcinoma resulted in a complete response (PMID: 34301750; NCT02264613).	34301750
TP53 wild-type	peripheral T-cell lymphoma	predicted - sensitive	ALRN-6924	Case Reports/Case Series	Actionable	In a Phase I trial, ALRN-6924 treatment in a patient with peripheral T-cell lymphoma resulted in a complete response (PMID: 34301750; NCT02264613).	34301750
TP53 wild-type	colorectal cancer	predicted - sensitive	ALRN-6924	Case Reports/Case Series	Actionable	In a Phase I trial, ALRN-6924 treatment resulted in a partial response in a patient with colorectal cancer (PMID: 34301750; NCT02264613).	34301750
TP53 wild-type	acute myeloid leukemia	sensitive	ALRN-6924	Preclinical - Patient cell culture	Actionable	In a preclinical study, ALRN-6924 inhibited growth of cells derived from patients with TP53 wild-type acute myeloid leukemia in culture, and inhibited leukemia cell growth, prolonged survival in cell line xenograft models (PMID: 29643228).	29643228
TP53 loss	acute myeloid leukemia	resistant	ALRN-6924	Preclinical - Cell culture	Actionable	In a preclinical study, ALRN-6924 did not inhibit the growth of TP53-null acute myeloid leukemia cells in culture (PMID: 29643228).	29643228
TP53 R248Q	acute myeloid leukemia	resistant	ALRN-6924	Preclinical - Cell culture	Actionable	In a preclinical study, ALRN-6924 did not inhibit the growth of acute myeloid leukemia cells harboring TP53 R248Q in culture (PMID: 29643228).	29643228

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02264613	Phase Ib/II	ALRN-6924	Safety Study of ALRN-6924 in Patients With Advanced Solid Tumors	Completed	USA	0
NCT02909972	Phase I	ALRN-6924 + Cytarabine ALRN-6924	Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome	Completed	USA	0
NCT03654716	Phase I	ALRN-6924 + Cytarabine ALRN-6924	Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer	Completed	USA	0

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