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

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

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).

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: NOV140101 (IDX-1197)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Limiting Toxicities (DLTs)	Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21)

Collaborators and Investigators

• Sponsor: Idience Co., Ltd.
• Collaborators: National OncoVenture; IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): December 8, 2020
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: 1197; venadaparib; IDX-1197
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: NOV140101-101/ID-VDP-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No