drugset / Trial / NCT04262739

MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors

NCT04262739 ↗

Phase 1 Unknown 42 enrolled Haim Bio Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

The objectives of this study are: Part 1: * To assess the MTD, safety and efficacy of each NYH817G and NYH100P in monotherapy in patients with advanced solid tumors who have failed approved standard therapies. * To assess the PK properties and the preliminary effectiveness of monotherapy of NYH817G and NYH100P. Part 2: * To assess the MTD, RP2D, safety and efficacy of NYH817G and NYH100P in combination therapy in patients with advanced solid tumors who have failed approved standard therapies * To assess the PK properties, the preliminary effectiveness and the changes in metabolism of combination therapy of NYH817G and NYH100P.

Timeline

Start
2019-12-18
Primary completion
2021-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NYH100P Unknown 100 mg Oral
Subject NYH817G Unknown 15 mg Oral

Indications