Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625515
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
First-in-Human Study of ATX-559 an Oral Inhibitor of DHX9 in Patients with Advanced or Metastatic Solid Tumors and Molecularly Defined Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Open-Label Dose-Escalation and Expansion First-In-Human Study of ATX-559 an Oral Inhibitor of the Helicase DHX9 in Patients with Locally Advanced or Metastatic Solid Tumors and Molecularly Defined Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to identify a safe and tolerated dose of the orally administered DHX9 inhibitor ATX-559 In addition this study will evaluate the pharmacokinetics pharmacodynamics and preliminary antitumor activity of ATX-559 in patients with advanced solid tumors and molecularly defined cancers
Detailed Description:
ATX-559 is an oral drug that inhibits a protein called DHX9 a multi-functional RNA helicase that is involved in the maintenance of genomic stability by resolving DNARNA secondary structures that may lead to DNA replication stress and DNA damage in certain molecularly defined cancers ATX-559 has been shown preclinically to induce robust anti-tumor activity of a variety of different solid tumors including models with BRCA deficiency and microsatellite instability-high MSI-H andor deficient mismatch repair dMMR
This is a first-in-human Phase 1 open-label single-arm dose-escalation and expansion study to
Evaluate the safety profile of ATX-559 and determine the recommended phase 2 dose RP2D In addition the study aims to characterize the PK PD and preliminary anti-tumor activity of orally administered ATX-559 Exploratory objectives include examination of biomarker responses in relationship to ATX-559 exposure
Patients with molecularly selected locally advanced or metastatic solid tumors for example BRCA1- or BRCA2-deficient breast cancer and solid tumors with microsatellite instability MSI-H andor deficient mismatch repair dMMR will be enrolled to preliminarily assess the anti-tumor effect and further examine the safety and PK of ATX-559 at the RP2D
This is a first-in-human Phase 1 open-label single-arm dose-escalation and expansion study to
Evaluate the safety profile of ATX-559 and determine the recommended phase 2 dose RP2D In addition the study aims to characterize the PK PD and preliminary anti-tumor activity of orally administered ATX-559 Exploratory objectives include examination of biomarker responses in relationship to ATX-559 exposure
Patients with molecularly selected locally advanced or metastatic solid tumors for example BRCA1- or BRCA2-deficient breast cancer and solid tumors with microsatellite instability MSI-H andor deficient mismatch repair dMMR will be enrolled to preliminarily assess the anti-tumor effect and further examine the safety and PK of ATX-559 at the RP2D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None