Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS) (VASTUS)
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|ClinicalTrials.gov Identifier: NCT04174716|
Recruitment Status : Active, not recruiting
First Posted : November 22, 2019
Last Update Posted : March 1, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Homologous Recombination Repair Gene Mutation Homologous Recombination Deficiency||Drug: IDX-1197||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors|
|Actual Study Start Date :||November 6, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Patient will be receive IDX-1197HCl once daily for 28 continuous days
Until progression or unacceptable toxicity develops
- 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).
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174716
|Responsible Party:||Idience Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||November 22, 2019 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|