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

• Sponsor: Handok Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04014257
• Collaborator: CMG Pharmaceutical Co. Ltd (Industry)
• Enrollment: 17
• Locations: 4
• Arm: 1
• Actual Duration (Months): 17.7
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

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

• Study Type: Interventional
• Actual Enrollment: 17 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: Aug 9, 2019
• Actual Primary Completion Date: Jan 22, 2021
• Actual Study Completion Date: Jan 29, 2021

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 [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) [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

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang	Gyeonggi-do	Korea, Republic of
2	CHA Bundang Medical Center	Seongnam	Gyeonggi-do	Korea, Republic of
3	Seoul National University Hospital	Seoul		Korea, Republic of
4	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Handok Inc.
• CMG Pharmaceutical Co. Ltd

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT04014257
• Other Study ID Numbers: NOV160101-101
• First Posted: Jul 10, 2019
• Last Update Posted: Sep 16, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Handok Inc.: tropomyosin receptor kinase; Solid organ malignancies
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Sep 16, 2021