Clinical trial NCT04014257: A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Phase 1
Solid Tumor, Adult
Keywords: tropomyosin receptor kinase
Solid organ malignancies
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
Collaborators: name: CMG Pharmaceutical Co. Ltd
First posted: 2019-07-10
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
timeFrame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).
Secondary outcomes:
measure: Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)
timeFrame: Maximum 2 years
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Dong-Wan Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Center
name: Tak Yun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Sang-Joon Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA Bundang Medical Center
name: Yong-Wha Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: