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

NCT04014257 | Completed Phase 1

• 1 other identifier: NOV160101-101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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.

Conditions

Phase 1; Solid Tumor, Adult

Keywords

tropomyosin receptor kinase; Solid organ malignancies

Outcome Measures

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).

  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)

  Maximum 2 years

Study Arms (1)

NOV1601(CHC2014)

EXPERIMENTAL

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

NOV1601(CHC2014) DRUG

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)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead
• CMG Pharmaceutical Co. Ltd: collaborator

Study Sites (4)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 10, 2019
• Study Start: August 9, 2019
• Primary Completion: January 22, 2021
• Study Completion: January 29, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-08

Locations

KR (4)