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CompletedNCT04014257Updated Sep 16, 2021

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

A Phase 1 interventional study of NOV1601(CHC2014) in Phase 1 and Solid Tumor, Adult, sponsored by Handok Inc.. Completed at 4 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Handok Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
19 Years and older
Sex
All
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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.

Read the detailed description

This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.

Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).

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Conditions studied

  • Phase 1
  • Solid Tumor, Adult

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Keywords

  • tropomyosin receptor kinase
  • Solid organ malignancies
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 17 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Handok Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
  • At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO)
  • Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable

  • Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable

    • Symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment
    • Stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study
    • Subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(C1D1) without symptom aggravation

Exclusion criteria

Exclusion Criteria(partial):

  • Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation
  • History or evidence of suspicious leptomeningeal disease
  • Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule
  • Indwelling percutaneous drainage of bile and chest tube
  • Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    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)

    Drug: NOV1601(CHC2014)

Interventions

  • DrugNOV1601(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)

06

What researchers measure

Primary outcomes

  1. the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601

    MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).

    Time frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).

Secondary outcomes

  1. Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)

    Each adverse event will be coded using the Medical Dictionary for Regulatory Activities(version 20.0) classification system. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Time frame: Maximum 2 years

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Study locations

4 sites
  • National Cancer Center
    Goyang, Gyeonggi-do, Korea, Republic of
  • CHA Bundang Medical Center
    Seongnam, Gyeonggi-do, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
  • Severance Hospital
    Seoul, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04014257
Lead sponsor
Handok Inc.
Collaborators
CMG Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Jul 10, 2019
Start date
Aug 9, 2019
Primary completion
Jan 22, 2021
Completion
Jan 29, 2021
Last update
Sep 16, 2021

Study contacts

Dong-Wan Kim, MD, PhD
principal investigator · Seoul National University Hospital
Tak Yun, MD, PhD
principal investigator · National Cancer Center
Sang-Joon Shin, MD, PhD
principal investigator · Severance Hospital
Yong-Wha Moon, MD, PhD
principal investigator · CHA Bundang Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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