Therapy Detail

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Adavosertib		MK-1775\|AZD1775\|AZ1775\|MK1775	WEE1 Inhibitor 8	Adavosertib (MK-1775) is a small molecule inhibitor of the tyrosine kinase WEE1 with potential antineoplastic sensitizing activity (PMID: 22084170, PMID: 32611648).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
NRAS mut TP53 mut	colorectal cancer	no benefit	Adavosertib	Phase II	Actionable	In a Phase II trial (FOCUS4-C), Adavosertib (AZD1775) treatment was well-tolerated and resulted in an advantage in progression-free survival (PFS, HR 0.40, p=0.0051) but not overall survival (0.92, p=0.93) compared to active monitoring in patients with metastatic colorectal cancer harboring both RAS and TP53 mutations, however, patients with NRAS mutations or KRAS non-G12/G13 mutations did not benefit from Adavosertib (AZD1775) treatment in subgroup PFS analysis (PMID: 34538072).	34538072
TP53 mutant	Advanced Solid Tumor	predicted - sensitive	Adavosertib	Phase I	Actionable	In a Phase I trial, Adavosertib (MK-1775) treatment resulted in a prtial response in 3 and progressive disease in 2 of 6 patients with advanced solid tumors harboring TP53 mutations (J Clin Oncol 38: 2020 (suppl; abstr 3624); NCT01748825).	detail...
TP53 mutant	Advanced Solid Tumor	predicted - sensitive	Adavosertib	Phase I	Actionable	In a retrospective analysis of a Phase I trial, Adavosertib (MK-1775) combined with a chemotherapy resulted in a 21% (4/19) response rate in advanced solid tumor patients harboring a TP53 mutation and in those without a TP53 mutation, a 12% (4/33) response rate was observed (PMID: 27601554; NCT00648648).	27601554
TP53 mutant	endometrial carcinoma	predicted - sensitive	Adavosertib	Case Reports/Case Series	Actionable	In a Phase I trial, Adavosertib (MK-1775) treatment resulted in a partial response (PR) in 17% (6/35) of patients with advanced solid tumors, 2 of the patients achieved PR had endometrial carcinoma (EC), and TP53 mutations were identified in 1 of the EC patients with biopsy available for genomic analysis (J Clin Oncol 38: 2020 (suppl; abstr 3624); NCT01748825).	detail...
TP53 mutant	ovarian carcinoma	predicted - sensitive	Adavosertib	Case Reports/Case Series	Actionable	In a Phase I trial, Adavosertib (MK-1775) treatment resulted in a partial response (PR) in 17% (6/35) of patients with advanced solid tumors, 4 of the patients achieved PR had ovarian carcinoma (OVC), and TP53 mutations were identified in 2 of the OVC patients with biopsies available for genomic analysis (J Clin Oncol 38: 2020 (suppl; abstr 3624); NCT01748825).	detail...
TP53 mutant	glioblastoma	sensitive	Adavosertib	Preclinical - Pdx	Actionable	In a preclinical study, treatment with Adavosertib (MK-1775) decreased CDK1 phosphorylation and reduced tumor growth in patient-derived xenograft models of glioblastoma multiforme that harbor TP53 mutations (PMID: 27196784).	27196784
KIT exon 11 del	gastrointestinal stromal tumor	no benefit	Adavosertib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Adavosertib (MK-1775) treatment resulted in reduced cell viability of gastrointestinal stromal tumor cells harboring a KIT exon 11 deletion in culture, but did not lead to improved tumor growth inhibition or prolonged survival compared to controls in cell line xenograft models (PMID: 33320833).	33320833
TP53 mutant	esophagus adenocarcinoma	predicted - sensitive	Adavosertib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Adavosertib (MK-1775) treatment inhibited phosphorylation of Wee1 and Cdk1, and reduced viability of TP53-mutant esophageal adenocarcinoma cells in culture, and led to partial tumor growth delay in cell line xenograft models (PMID: 32220892).	32220892
FBXW7 del	Advanced Solid Tumor	sensitive	Adavosertib	Preclinical - Cell culture	Actionable	In a preclinical study, a cell line with knockout of FBXW7 demonstrated increased sensitivity to Adavosertib (MK-1775) compared to cells with wild-type FBXW7 in culture (PMID: 38032106).	38032106
FBXW7 R465H	cervical cancer	sensitive	Adavosertib	Preclinical - Cell culture	Actionable	In a preclinical study, a cervical cancer cell line harboring FBXW7 R465H demonstrated increased sensitivity to Adavosertib (MK-1775) treatment compared to a cell line with wild-type FBXW7 in culture (PMID: 38032106).	38032106
TP53 mutant	esophagus squamous cell carcinoma	predicted - sensitive	Adavosertib	Preclinical - Cell culture	Actionable	In a preclinical study, Adavosertib (MK-1775) treatment inhibited viability of TP53-mutant esophageal squamous cell carcinoma cells in culture (PMID: 32220892).	32220892
NRAS mutant	melanoma	sensitive	Adavosertib	Preclinical	Actionable	In a preclinical study, Adavosertib (MK-1775) showed efficacy in NRAS mutant melanoma and in mutant KRAS colorectal, pancreatic, and lung cancers (PMID: 24791855).	24791855
TP53 loss	Advanced Solid Tumor	sensitive	Adavosertib	Preclinical	Actionable	In a preclinical study, tumor cell lines carrying deficient TP53 were sensitized to DNA-damaging agents upon Adavosertib (MK-1775) administration (PMID: 19887545).	19887545

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02465060	Phase II	Erdafitinib Trametinib Crizotinib Sapanisertib Fexagratinib Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	Active, not recruiting	USA	2
NCT02659241	Phase I	Adavosertib	A Pilot Study of Induction Wee1 Inhibition in Ovarian Cancer	Active, not recruiting	USA	0
NCT03284385	Phase II	Adavosertib	Testing AZD1775 in Advanced Solid Tumors That Have a Mutation Called SETD2	Active, not recruiting	USA	0
NCT03385655	Phase II	Savolitinib Darolutamide Adavosertib	Prostate Cancer Biomarker Enrichment and Treatment Selection	Active, not recruiting	CAN	0
NCT03668340	Phase II	Adavosertib	AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma	Active, not recruiting	USA	0
NCT04460937	Phase I	Adavosertib	Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers	Active, not recruiting	USA	0
NCT01357161	Phase II	Carboplatin Adavosertib Paclitaxel	A Study of MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)	Completed		0
NCT01748825	Phase I	Adavosertib	MK-1775 for Advanced Solid Tumors	Completed	USA	0
NCT01922076	Phase I	Adavosertib	WEE1 Inhibitor MK-1775 and Local Radiation Therapy in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas	Completed	USA \| CAN	0
NCT02194829	Phase Ib/II	Paclitaxel Gemcitabine Adavosertib	Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery	Completed	USA	0
NCT02341456	Phase I	Adavosertib Carboplatin Paclitaxel	Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours	Completed	AUS	2
NCT02508246	Phase I	Adavosertib Docetaxel Cisplatin	AZD1775, Docetaxel, and Cisplatin Before Surgery in Treating Patients With Borderline Resectable Stage III-IVB Squamous Cell Carcinoma of the Head and Neck	Completed	USA	0
NCT02511795	Phase I	Adavosertib Olaparib	AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors	Completed	USA \| CAN	0
NCT02513563	Phase II	Carboplatin + Paclitaxel Adavosertib	AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer	Completed	USA	0
NCT02610075	Phase I	Adavosertib	Study to Determine MTD of AZD1775 Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumours.	Completed	USA	0
NCT02666950	Phase II	Adavosertib Cytarabine	WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome	Completed	USA	0
NCT03253679	Phase II	Adavosertib	WEE1 Inhibitor AZD1775 in Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification	Completed	USA	0
NCT03313557	Phase I	Adavosertib	AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies	Completed	USA \| NLD \| GBR \| FRA	0
NCT03333824	Phase I	Adavosertib	Effects of AZD1775 on the PK Substrates for CYP3A, CYP2C19, CYP1A2 and on QT Interval in Patients With Advanced Cancer	Completed	USA	0
NCT04590248	Phase II	Adavosertib	A Study of Adavosertib as Treatment for Uterine Serous Carcinoma (ADAGIO)	Completed	USA \| ITA \| FRA \| ESP \| CAN	0
NCT02087176	Phase II	Adavosertib Pegfilgrastim	A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer	Terminated	USA	0
NCT02087241	Phase II	Adavosertib Carboplatin + Pemetrexed Disodium	Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer	Terminated	USA	0
NCT02196168	Phase II	Adavosertib Cisplatin	Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer	Terminated	CAN	0
NCT04949425	Phase I	Adavosertib	A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours	Terminated	USA \| GBR	0
NCT02791919	Phase I	Adavosertib Cytarabine + Filgrastim + Fludarabine	Wee1 Kinase Inhibitor AZD1775 and Combination Chemotherapy in Treating Children, Adolescents and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia	Withdrawn		0

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