Solid TumorsPhase 1/2VASTUSNCT04174716
Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS)
A Phase 1/2 study testing IDX-1197 in people with Solid Tumors and Homologous Recombination Repair Gene Mutation, run by Idience Co., Ltd. at 19 sites in South Korea.
Trial summary
This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation. There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumors, Homologous Recombination Repair Gene Mutation, Homologous Recombination Deficiency
- What is being tested?
- IDX-1197
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 19 sitesSouth Korea
- Study dates
- 6 Nov 2019to 28 Jun 2024
- Phase
- Phase 1/2
- 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
- Histologically confirmed cancers that have HRR mutation and are failed to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
- Measurable disease according to RECIST, v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- Must have recovered from all side effects of their most recent systemic or local treatment (<CTCAE grade 3)
- Life expectancy greater than 12weeks
Who cannot join
- Prior treatment with PARP inhibitors
- Symptomatic CNS metastases
- History of or known carcinomatous meningitis
- Concurrent administration of any anti-cancer therapies other than those administered in this study
- Pregnant or lactating women
- Refractory nausea and vomiting, malabsorption, total gastrectomy, external biliary shunt or significant bowel resection that would preclude adequate absorption.
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- Uncontrolled medical illness (such as infection requiring treatment with intravenous antibiotics)
- Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment or New York Heart Association (NYHA) Class II to IV heart disease.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
- Known hypersensitivity to IDX-1197 or any of the excipients of the product
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Inje University Haeundae Hospital
Busan, 48108
Dong-a University Hospital
Busan, 49201
Pusan National University Yangsan Hospital
Busan, 50612
National Cancer Centre
Goyang, Gyeongggi-do, 10408
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Gachon University Gil Medical Center
Incheon, 21565
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Cha University Bundang Medical Center
Seongnam-si, 13496
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 08308
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
About this study
Official title: An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors
This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation.
There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D.
- Conditions
- Solid Tumors, Homologous Recombination Repair Gene Mutation, Homologous Recombination Deficiency
- Being tested
- IDX-1197
- Keywords
- HRR, 1197, venadaparib, IDX-1197
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDX-1197Drug
Until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| IDX-1197 | Experimental | Patient will be receive IDX-1197HCl once daily for 28 continuous days Receives: Drug: IDX-1197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Confirmed objective response rate (ORR) determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1).
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start6 Nov 2019
- Primary completion31 Mar 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174716
- Sponsor's protocol ID
- ID-VDP-102
- Acronym
- VASTUS
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2019
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors
- ClinicalTrials.gov ID
- NCT04174716
- Acronym / sponsor ID
- VASTUS / ID-VDP-102
- Conditions
- Solid Tumors, Homologous Recombination Repair Gene Mutation, Homologous Recombination Deficiency
- Keywords
- HRR, 1197, venadaparib, IDX-1197
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Idience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 22 Nov 2019 (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.
This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation.
There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDX-1197 | Experimental | Drug: IDX-1197Patient will be receive IDX-1197HCl once daily for 28 continuous days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed cancers that have HRR mutation and are failed to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
- Measurable disease according to RECIST, v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- Must have recovered from all side effects of their most recent systemic or local treatment (<CTCAE grade 3)
- Life expectancy greater than 12weeks
Key exclusion criteria (10 listed)
- Prior treatment with PARP inhibitors
- Symptomatic CNS metastases
- History of or known carcinomatous meningitis
- Concurrent administration of any anti-cancer therapies other than those administered in this study
- Pregnant or lactating women
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 |
|---|---|---|
| IDX-1197Until progression or unacceptable toxicity develops | Drug | IDX-1197 |
Primary outcome
objective response rate (ORR)
Time frame: Up to 24 weeks
Confirmed objective response rate (ORR) determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1).
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.
- Individual participant dataSharing planned: Undecided
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDX-1197 in people with Solid Tumors and Homologous Recombination Repair Gene Mutation, run by Idience Co., Ltd. at 19 sites 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 5 inclusion and 10 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 19 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
objective response rate (ORR) (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.