Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05116683
Status:
TERMINATED
Last Update Posted:
2023-12-06
First Post:
2021-10-18
Brief Title:
ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma
Sponsor:
Benjamin Izar
Organization:
Columbia University
Study Overview
Official Title:
A Phase II Study With a Safety lead-in to Evaluate ATX-101 a Peptide Drug Targeting PCNA in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by PI
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATX-101
Brief Summary:
The purpose of this study is to evaluate the effectiveness of a new investigational drug ATX-101 for the treatment of dedifferentiated liposarcoma LPS and leiomyosarcoma LMS ATX-101 is an intravenous IV drug which blocks the interaction of a protein called PCNA with a number of stress response proteins These interactions are thought to be important for cancer cell survival and growth ATX-101 may disrupt these interactions and therefore help treat the cancer In this study all patients will receive the same treatment Most of the exams tests and procedures are part of the usual approach to medical care for this condition However some additional tests or procedures may be performed and other tests may be performed more frequently than usual
Detailed Description:
ATX-101 is a small molecule peptide comprised of a novel human proliferating cell nuclear antigen PCNA interacting motif termed APIM coupled to cellular and nuclear delivery domains PCNA interacts with many cellular proteins and exerts pleiotropic effects in the cancer cell Proteins that bind to PCNA via APIM are especially important in the cellular stress and DNA damage responses as well as intracellular signaling apoptosis metabolism and anti-tumor immunity In preclinical studies ATX-101 demonstrated single-agent activity and potentiated other cytotoxic and targeted agents across multiple cancer models in vitro and in vivo including LMS and LPS ATX-101 is currently being evaluated in a phase 1 safety and pharmacokinetic study in solid tumors using a 3 3 dose escalation design As of 10292020 ATX-101 has been evaluated across dose levels of 20 mgm2 - 60 mgm2 IV weekly Although no maximum tolerated dose MTD was reached after review of the available safety data the RP2D was determined to be 60 mgm2 IV weekly with no plans to dose escalate further ATX-101 has been well tolerated with no grade 3 or higher adverse events AEs observed during the phase 1 study Common AEs include grade 12 infusion related reactions which have been easily managed with supportive care mild fatigue and diarrhea In this study ATX-101 demonstrated encouraging activity as prolonged disease stabilization in patients with progressive heavily pre-treated malignancies
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