Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04991480
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2021-07-19
Brief Title:
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
Sponsor:
Artios Pharma Ltd
Organization:
Artios Pharma Ltd
Study Overview
Official Title:
A Phase IIIa Open-label Multi-centre Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors The main goals of this study are to
Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib
Learn more about the side effects of ART4215 alone and in combination with talazoparib
Learn more about the effectiveness of ART4215 alone and in combination with talazoparib
Learn more about the effectiveness of ART4215 alone and in combination with niraparib
Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib
Learn more about the side effects of ART4215 alone and in combination with talazoparib
Learn more about the effectiveness of ART4215 alone and in combination with talazoparib
Learn more about the effectiveness of ART4215 alone and in combination with niraparib
Detailed Description:
This is an open-label Phase IIIa study designed to evaluate ART4215 a new first-in-class investigational medicinal product that is a potent and selective inhibitor of deoxyribonucleic acid DNA polymerase pol theta ART4215 is being developed as an oral anti-cancer agent for monotherapy treatment of patients with cancers that harbor defects in DNA repair and in combination with anticancer medicines that cause DNA damage
This study was intended to be a Phase IIIa trial however the trial did not proceed to the Phase IIa portion of the study
This study was intended to be a Phase IIIa trial however the trial did not proceed to the Phase IIa portion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None