Solid Tumor, Adult Clinical Trial
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
Verified date | August 2021 |
Source | Handok Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 29, 2021 |
Est. primary completion date | January 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center | Goyang | Gyeonggi-do |
Korea, Republic of | CHA Bundang Medical Center | Seongnam | Gyeonggi-do |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Handok Inc. | CMG Pharmaceutical Co. Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE) | 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. | Maximum 2 years |
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