NCT04746612

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HH30134	HH30134 administered orally on a continuous once daily(QD) in patients with advanced solid tumors

Timeline

• Start date: 2021-04-08
• Primary completion: 2023-03-24
• Completion: 2023-03-24
• First posted: 2021-02-10
• Last updated: 2023-03-30

Locations

4 sites across 2 countries: Australia, China