Spots Global Cancer Trial Database for A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

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Trial Identification

Brief Title: A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

Official Title: A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

Study ID: NCT04014257

Conditions

Phase 1

Solid Tumor, Adult

Interventions

NOV1601(CHC2014)

Study Description

Brief Summary: This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.

Detailed Description: This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies. Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).