drugset / Trial / NCT03036228

MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class

NCT03036228 ↗

Phase 1 Completed 63 enrolled Thomas Helleday Foundation
NaSequentialOpen-labelTreatment

Summary

Primary Objective • To determine the safety and tolerability of Karonudib (TH1579) in escalating doses for the treatment of patients with advanced solid malignant tumours. Secondary Objective * To define DLT and MTD. * To determine a recommended phase 2 dose (RP2D) and schedule. * To determine the pharmacokinetics of Karonudib. * To determine preliminary signs of clinical efficacy of Karonudib. * To determine overall survival.

Timeline

Start
2017-01-14
Primary completion
2024-12-17
Completion
2024-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Karonudib Unknown — Oral

Indications