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

NCT03317743 | Completed Phase 1

• 1 other identifier: NOV140101-101/ID-VDP-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Solid Tumors

Keywords

1197; IDX-1197; venadaparib

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLTs)

  Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21)

Study Arms (1)

NOV140101 (IDX-1197)

EXPERIMENTAL

Drug: NOV140101 (IDX-1197)

Interventions

NOV140101 (IDX-1197) DRUG

The dose levels will be escalated following a 3+3 dose escalation scheme.

NOV140101 (IDX-1197)

Eligibility Criteria

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

You may qualify if:

• ≥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:
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0g/dL
• Serum creatinine ≤ 1.5×ULN
• Total bilirubin ≤ 1.5×ULN
• AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell cancer)
• PT and aPTT ≤ 1.5×ULN
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Idience Co., Ltd.: lead
• IlDong Pharmaceutical Co Ltd: collaborator
• National OncoVenture: collaborator

Study Sites (1)

Asan Medical Center

Seoul, SONGPA-GU, 05505, South Korea

Location

Related Publications (1)

• Kim SB, Bae KS, Lee JL, Lee WS, Ock CY, Lee MJ, Bang J, Hong MJ, Roh EJ, Ha KS, Lim JH, Kim YM. First-In-Human Dose Finding Study of Venadaparib (IDX-1197), a Potent and Selective PARP Inhibitor, in Patients With Advanced Solid Tumors. Cancer Med. 2025 Feb;14(4):e70576. doi: 10.1002/cam4.70576.

  PMID: 39945311 DERIVED

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: October 18, 2017
• First Posted: October 23, 2017
• Study Start: August 29, 2017
• Primary Completion: December 8, 2020
• Study Completion: October 13, 2021
• Last Updated: April 17, 2026

Record last verified: 2021-11

Locations

KR (1)