Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT03317743
• Recruitment Status: Active, not recruiting
• First Posted: October 23, 2017
• Last Update Posted: January 15, 2021
• Sponsor: Idience Co., Ltd.
• Collaborators: IlDong Pharmaceutical Co Ltd; National OncoVenture
• Information provided by (Responsible Party): Idience Co., Ltd.

Study Description

Brief Summary:

the purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV140101 (IDX-1197).

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors	Drug: NOV140101 (IDX-1197)	Phase 1

Detailed Description:

This is an open-label, Phase 1 dose escalation study of NOV140101 (IDX-1197) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of IDX-1197 in patients with advanced solid tumors after failure of standard of care. DLTs will be assessed as the primary endpoint in this trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label, Phase I Clinical Trial to Identify Optimal Dose and Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Anti-cancer Efficacy of NOV140101(IDX-1197HCl) in Patients With Advanced Solid Tumors
• Actual Study Start Date: August 29, 2017
• Actual Primary Completion Date: December 8, 2020
• Estimated Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: NOV140101 (IDX-1197)	Drug: NOV140101 (IDX-1197); The dose levels will be escalated following a 3+3 dose escalation scheme.; Other Name: IDX-1197

Outcome Measures

Primary Outcome Measures :

1. Dose Limiting Toxicities (DLTs) [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21) ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• ≥19 year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
• Life expectancy ≥12 weeks
• Women of childbearing potential must have a negative pregnancy test outcome
• ECOG performance status ≤2
• Lesions measured by tumor markers or CT/MRI and evaluable according to RECIST v1.1

• Patient must have adequate organ function as indicated by the following laboratory values independent of transfusion within 2 weeks:

  1. ANC ≥ 1,500/mm³
  2. Platelet count ≥ 100,000/mm³
  3. Hemoglobin ≥ 9.0g/dL
  4. Serum creatinine ≤ 1.5×ULN
  5. Total bilirubin ≤ 1.5×ULN
  6. AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell cancer)
  7. PT and aPTT ≤ 1.5×ULN
  8. UPC < 1.0 g/g (one re-test is allowed if positive (≥ 1))
• Patients must provide written informed consent to voluntary participation in this study.

Exclusion Criteria:

• History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
• New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled hypertension (systolic/diastolic blood pressure >140/90mmHg), or other clinically significant cardiovascular abnormalities in the opinion of the investigator
• Uncontrolled cardiac arrhythmia
• Acute coronary syndrome (unstable angina pectoris or myocardial infarction) within the past 6 months
• Major electrocardiogram (ECG) abnormalities in the opinion of the investigator
• Severe infection or severe traumatism
• Pneumonia or respiratory symptoms, such as dyspnea, cough, and fever, requiring treatment and other conditions likely to be accompanied by hypoxemia
• History of drug or alcohol abuse within the past 3 months
• Symptomatic or uncontrolled central nervous system (CNS) metastasis
• Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
• Radiotherapy, hormone therapy, or chemotherapy within 2 weeks prior to baseline from which toxicities not recovered to ≤grade 1
• >4 weeks of persistent Grade 3 (NCI-CTCAE v4.03) hematologic toxicities from prior anticancer treatment
• History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS or acute myelocytic leukemia
• Ongoing or anticipated treatment with antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) during the study
• Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
• Ongoing or past treatment with immunosuppressants within 14 days prior to the first dose of study treatment, except for intranasal, inhaled, topical, or locally injected (e.g., intraarticular injection) steroids
• History of serious gastrointestinal bleedings within 12 weeks prior to screening or presence of diseases that may affect oral drug absorption (e.g., malabsorption syndrome, active peptic ulcer)
• History of human immunodeficiency virus infection or active hepatitis B or C infection or ongoing uncontrolled chronic infectious disease
• Pregnant or lactating women or patients planning to become pregnant during the study
• Participation in another clinical trial within 30 days prior to screening
• Individual considered ineligible for this study for other reasons, in the opinion of the investigator

Contacts and Locations

Locations

Korea, Republic of

Asan Medical Center

Seoul, Songpa-gu, Korea, Republic of, 05505

Sponsors and Collaborators

Idience Co., Ltd.

IlDong Pharmaceutical Co Ltd

National OncoVenture

More Information

• Responsible Party: Idience Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03317743
• Other Study ID Numbers: NOV140101-101/ID-VDP-101
• First Posted: October 23, 2017
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms