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

Phase 1

Completed

• Conditions: Solid Tumor, Adult; Phase 1
• Interventions: Drug: NOV1601(CHC2014)

• Registration Number: NCT04014257
• Lead Sponsor: Handok Inc.

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 Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Study Start: 2019-08-09
• Primary Completion: 2021-01-22
• Study Completion: 2021-01-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOV1601(CHC2014)	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (4)

CHA Bundang Medical Center; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of