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A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

NCT04014257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

  • Phase 1
  • Solid Tumor, Adult

Interventions

DRUG

NOV1601(CHC2014)

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)

Sponsors & Collaborators

  • CMG Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Handok Inc.

    lead INDUSTRY

Principal Investigators

  • Dong-Wan Kim, MD, PhD · Seoul National University Hospital

  • Tak Yun, MD, PhD · National Cancer Center

  • Sang-Joon Shin, MD, PhD · Severance Hospital

  • Yong-Wha Moon, MD, PhD · CHA Bundang Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2021-01-22
Completion
2021-01-29

Countries

  • South Korea

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 NCT04014257 on ClinicalTrials.gov