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出境医 / 临床实验 / A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Phase 1 Solid Tumor, Adult Drug: NOV1601(CHC2014) Phase 1

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
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)
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)
Outcome Measures
Primary Outcome Measures :
  1. the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601 [ Time Frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28). ]
    MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE) [ Time Frame: Maximum 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria(partial):

  • 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(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
Contacts and Locations

Contacts
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Contact: Hoon-Kyo Kim, MD, PhD 82 31 920 2781 miongos@ncc.re.kr
Contact: Sang Yoon Lee, MD 82 2 527 5204 SangYoon.Lee@handok.com

Locations
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Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi-do, Korea, Republic of
Contact: Tak Yun, MD, PhD         
CHA Bundang Medical Center Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of
Contact: Yong-Wha Moon, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong-Wan Kim, MD, PhD         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang-Joon Shin, MD, PhD         
Sponsors and Collaborators
National OncoVenture
Handok Inc.
CMG Pharmaceutical Co. Ltd
Investigators
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Principal Investigator: Dong-Wan Kim, MD, PhD Seoul National University Hospital
Principal Investigator: Tak Yun, MD, PhD National Cancer Center
Principal Investigator: Sang-Joon Shin, MD, PhD Severance Hospital
Principal Investigator: Yong-Wha Moon, MD, PhD CHA Bundang Medical Center
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601 [ Time Frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28). ]
MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE) [ Time Frame: Maximum 2 years ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
Official Title  ICMJE A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
Brief 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Phase 1
  • Solid Tumor, Adult
Intervention  ICMJE 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)
Study Arms  ICMJE 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)
Intervention: Drug: NOV1601(CHC2014)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria(partial):

  • 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(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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hoon-Kyo Kim, MD, PhD 82 31 920 2781 miongos@ncc.re.kr
Contact: Sang Yoon Lee, MD 82 2 527 5204 SangYoon.Lee@handok.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014257
Other Study ID Numbers  ICMJE NOV160101-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National OncoVenture
Study Sponsor  ICMJE National OncoVenture
Collaborators  ICMJE
  • Handok Inc.
  • CMG Pharmaceutical Co. Ltd
Investigators  ICMJE
Principal Investigator: Dong-Wan Kim, MD, PhD Seoul National University Hospital
Principal Investigator: Tak Yun, MD, PhD National Cancer Center
Principal Investigator: Sang-Joon Shin, MD, PhD Severance Hospital
Principal Investigator: Yong-Wha Moon, MD, PhD CHA Bundang Medical Center
PRS Account National OncoVenture
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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