Phase I Study of HL-085 in Patients With Advanced Solid Tumors
NCT ID: NCT03976050
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2019-06-17
2020-11-12
Brief Summary
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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?
Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation
Subjects in the dose escalation cohorts will receive ascending doses of HL-085 until the MTD is determined. The first three subjects will receive twice-daily doses (BID) of HL-085 6 mg. Additional cohorts may receive doses of HL-085 9, 12 or 18 mg BID respectively and sequentially. If DLTs are observed in \<33.3% of subjects at the 18 mg dose.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have at least one measurable lesion as defined by RECISTv1.1 criteria for solid tumors.
3. Must have received biological chemotherapy, immunotherapy or radiotherapy ≥4 weeks prior to starting the study treatment. Must have received small molecule chemotherapy ≥2 weeks or five half-lives (whichever is longer) prior to starting the study treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. Life expectancy ≥3 months (as judged by the Investigator).
6. Must have adequate hematologic, hepatic and renal function.
Exclusion Criteria
2. Known hypersensitivity to IP ingredients or their analogues.
3. Prior therapy with a MEK-inhibitor
4. Receipt of any other investigational agent therapy within 4 weeks prior to starting study treatment.
5. Any concurrent therapy for cancer treatment.
6. Have active central nervous system lesion.
7. Receiving and unable to discontinue medication which are strong inducers, strong inhibitors or enzyme substrates of cytochrome P450 CYP2C9 and CYP2C19 from 14 days prior to treatment.
8. Grade 3 bleeding symptoms (NCI-CTCAE v5.0) within 4 weeks prior to starting study treatment.
9. Unable to swallow IP or has refractory nausea and vomiting, malabsorption, external biliary diversion, or any significant small bowel resection that may interfere with adequate absorption of IP.
10. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
11. Left ventricular ejection fraction (LVEF) \<50%.
12. History major cerebrovascular diseases within 6 months prior to enrollment.
13. Infectious diseases requiring systemic treatment.
14. History or current evidence of retinal diseases.
15. Have active/chronic infection with hepatitis C, or positive hepatitis B surface antigen (HBsAg), or active/chronic infection with human immunodeficiency virus (HIV).
16. Known active tuberculosis.
17. History of allogeneic bone marrow transplantation or organ transplantation.
18. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
19. Pregnant or breast-feeding females.
20. Previous or history of second malignancy within 5 years prior to study treatment
21. Other conditions which may increase the risk associated with study participation, or interfere with the evaluation of study results.
18 Years
ALL
No
Sponsors
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Shanghai Kechow Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yi Liu, MD, PhD
Role: STUDY_DIRECTOR
KeChow Pharma
Locations
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Livestrong Cancer Institute, Dell Medical School, The University of Texas at Austin
Austin, Texas, United States
Next Oncology
San Antonio, Texas, United States
Countries
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Other Identifiers
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HL-085-US-101
Identifier Type: -
Identifier Source: org_study_id