A Phase 1 Study of the Polymerase Theta Inhibitor Novobiocin in BRCA-Mutant and Other DNA Damage Repair-Deficient Solid Tumors
Brief description of study
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of novobiocin administered on a 5-days on/2-days off schedule in patients with solid tumors carrying homologous recombination (HR) or DNA damage repair (DDR) alterations that are PARP inhibitor- naïve or -resistant. Standard hematological and non-hematologic parameters, scored using CTCAE v.5.0, will be used to define dose-limiting toxicity (DLT).
Clinical Study Identifier: s23-00981
ClinicalTrials.gov Identifier: NCT05687110
Principal Investigator:
Nancy Chan.
Other Investigators:
Elaine Shum,
Danny Perlaza,
Scot Niglio,
Yoke Wah Khoo,
Kirby Rodriguez,
Janice Mehnert,
Maya Dimitrova,
Mariam M Cheaib,
Monica Rivera,
Joshua K Sabari,
Keriann M Scavone,
Marissa Rybstein,
Nina Beri,
Alexander A Hindenburg,
Eneil De La Pena,
Kathleen M Lutz,
David R. Wise,
Elka R Travis,
Salman Rafi Punekar,
Michelle Diane Swanson Lightfoot,
Jeffrey G Schneider,
Samantha VanMaanen,
Maria Francis,
Kristen Spencer,
James Newman,
Kathleen M Madden,
Michael Shusterman,
Bhavana Pothuri,
Matthew A. Ingham,
Douglas K Marks.
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