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NOV1601(CHC2014) for Clinical Trials
Phase 1
Waitlist Available
Led By Dong-Wan Kim, MD, PhD
Research Sponsored by National OncoVenture
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum 2 years
Awards & highlights
No Placebo-Only Group
Summary
This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.
Eligible Conditions
- Clinical Trials
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ maximum 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maximum 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
Secondary study objectives
Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NOV1601(CHC2014)Experimental Treatment1 Intervention
a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A(TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NOV1601(CHC2014)
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
National OncoVentureLead Sponsor
9 Previous Clinical Trials
345 Total Patients Enrolled
Handok Inc.Lead Sponsor
47 Previous Clinical Trials
12,405 Total Patients Enrolled
CMG Pharmaceutical Co. LtdIndustry Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
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