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

NCT03976050 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-11-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Kechow Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Yi Liu, MD, PhD · KeChow Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2020-11-12
Completion
2020-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976050 on ClinicalTrials.gov