drugset / Trial / NCT03654547

Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

NCT03654547

Phase 1 Completed 48 enrolled TransThera Sciences (Nanjing), Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part.

Timeline

Start
2019-01-08
Primary completion
2023-01-31
Completion
2024-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Tinengotinib Small molecule 1 mg Oral
Subject Tinengotinib Small molecule 5 mg Oral
Subject Tinengotinib Small molecule 20 mg Oral