NCT03976050

Phase I Study of HL-085 in Patients With Advanced Solid Tumors

A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Shanghai Kechow Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study drug, HL-085 is a MEK inhibitor with the potential indication for cancers. It is an oral medication to be given daily. The purposes of this study is to find answers to the following research questions: 1. What is the highest tolerable dose of HL-085 that can be given to subjects when given orally (by mouth) on a twice daily basis? 2. What are the side effects of HL-085? 3. How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HL-085	HL-085 is a MEK inhibitor with potential indication for cancers. it will be given twice daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative anti-tumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.

Timeline

• Start date: 2019-06-17
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2019-06-05
• Last updated: 2020-11-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study