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)

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)

NOV1601(CHC2014)

Dong-Wan Kim, MD, PhD

Tak Yun, MD, PhD

Sang-Joon Shin, MD, PhD

Yong-Wha Moon, MD, PhD

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.

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).

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

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

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

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.

CMG Pharmaceutical Co. Ltd

Handok Inc.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Amino Acids

Belizatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Number of cycles until progression or unacceptable toxicity develops.

TSR-011

Dmitri Bobilev, MD

TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including:

1. Anaplastic lymphoma kinase (ALK)
2. The tropomyosin-related kinases TRKA, TRKB, and TRKC

This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.

A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas

Phase 1, during the dose-escalation phase

Phase 1, during the dose escalation phase

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies	NCT04014257	Phase 1 Solid Tumor, Ad...	NOV1601(CHC2014...	19 Years -	Handok Inc.
A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas	NCT02048488	Solid Tumors Lymphomas	TSR-011	18 Years -	Tesaro, Inc.
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies	NCT04014257	Phase 1 Solid Tumor, Ad...	NOV1601(CHC2014...	19 Years -	Handok Inc.

Spots Global Cancer Trial Database for tropomyosin receptor kinase