biostudies-literatureMaldonado ENCATS NIH HHSNCI NIH HHS1793-1801https://www.ebi.ac.uk/biostudies/studies/S-EPMC11264598biostudies-literatureUnknown4(7)We sought to evaluate the efficacy of WEE1 inhibitor adavosertib in patients with solid tumor malignancies (cohort A) and clear cell renal cell carcinoma (ccRCC; cohort B). NCT03284385 was a parallel cohort, Simon two-stage, phase II study of adavosertib (300 mg QDAY by mouth on days 1-5 and 8-12 of each 21-day cycle) in patients with solid tumor malignancies harboring a pathogenic SETD2 mutation. The primary endpoint was the objective response rate. Correlative assays evaluated the loss of H3K36me3 by IHC, a downstream consequence of SETD2 loss, in archival tumor tissue. Eighteen patients were enrolled (9/cohort). The median age was 60 years (range 45-74). The median duration of treatment was 1.28 months (range 0-24+). No objective responses were observed in either cohort; accrual was halCancer research communicationsA Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170).PMC11264598UM1 CA186690UM1 CA186717UM1 CA186709UM1 TR004906UL1 TR001863P30 CA093373UM1 CA186689UM1 CA186688Trikalinos NAMaldonado EMahalingam DBalido CAggarwal RRTakebe NMunster PNRathmell WKShapiro GIRodon JParikh MBergsland EKKalebasty ARAshworth AKrings GLoRusso PBoerner SABurns TFfalseA Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170).We sought to evaluate the efficacy of WEE1 inhibitor adavosertib in patients with solid tumor malignancies (cohort A) and clear cell renal cell carcinoma (ccRCC; cohort B). NCT03284385 was a parallel cohort, Simon two-stage, phase II study of adavosertib (300 mg QDAY by mouth on days 1-5 and 8-12 of each 21-day cycle) in patients with solid tumor malignancies harboring a pathogenic SETD2 mutation. The primary endpoint was the objective response rate. Correlative assays evaluated the loss of H3K36me3 by IHC, a downstream consequence of SETD2 loss, in archival tumor tissue. Eighteen patients were enrolled (9/cohort). The median age was 60 years (range 45-74). The median duration of treatment was 1.28 months (range 0-24+). No objective responses were observed in either cohort; accrual was hal2024-01-01T00:00:00Z2024 Jul2026-06-02T09:09:07.071Z2025-02-18T23:19:04.551ZS-EPMC112645983892040710.1158/2767-9764.CRC-24-0213