Advanced Solid TumorsPhase 1NCT03317743
Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors
A Phase 1 study testing NOV140101 (IDX-1197) in people with Advanced Solid Tumors, run by Idience Co., Ltd. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- NOV140101 (IDX-1197)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Aug 2017to 13 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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:
Show all 15Show fewer
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- NOV140101 (IDX-1197)
- Keywords
- 1197, IDX-1197, venadaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOV140101 (IDX-1197)Drug
The dose levels will be escalated following a 3+3 dose escalation scheme.
| Study group | Role | What they receive |
|---|---|---|
| NOV140101 (IDX-1197) | Experimental | Not described Receives: Drug: NOV140101 (IDX-1197) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start29 Aug 2017
- Primary completion8 Dec 2020
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IlDong Pharmaceutical Co Ltd, National OncoVenture
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317743
- Sponsor's protocol ID
- NOV140101-101/ID-VDP-101
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2017
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39945311
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03317743
- Acronym / sponsor ID
- NOV140101-101/ID-VDP-101
- Conditions
- Advanced Solid Tumors
- Keywords
- 1197, IDX-1197, venadaparib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Idience Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- IlDong Pharmaceutical Co Ltd, National OncoVenture
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOV140101 (IDX-1197) | Experimental | Drug: NOV140101 (IDX-1197) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOV140101 (IDX-1197)The dose levels will be escalated following a 3+3 dose escalation scheme. | Drug | NOV140101 (IDX-1197) |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 39945311Kim 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.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOV140101 (IDX-1197) in people with Advanced Solid Tumors, run by Idience Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs) (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.