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First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:
A Phase I, Multi-centre, Open-Label, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH30134 in Patients With Advanced Solid Tumours

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and to determine the maximum tolerable dose (MTD) and/or recommended phase 2 dose (RP2D) of HH30134 administered orally on a continuous once daily (QD) schedule in adults patients with advanced solid tumors.

Clinical Trial Description

Study population This is a global study involving multi-countries and multi-sites. Approximately 60 patients will be enrolled from participation institutions from different countries. Enrollment in dose-escalation phase must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following the last line of therapy and at least one prior standard of care regimens, or tumor for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Enrollment in dose-expansion phase will be patients with selected solid tumors including but not limited to NSCLC and mCRC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04746612
Study type Interventional
Source Haihe Biopharma Co., Ltd.
Contact
Status Terminated
Phase Phase 1
Start date April 8, 2021
Completion date March 24, 2023
View Details
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