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 : Recruiting
First Posted : November 22, 2019
Last Update Posted : February 26, 2021
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 :||September 30, 2021|
|Estimated Study Completion Date :||March 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).
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
|Contact: Won Sik Leefirstname.lastname@example.org|
|Contact: Minju Hongemail@example.com|