Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978492
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-07-20
Brief Title:
A Study of TXN10128 in Subjects With Solid Tumors
Sponsor:
Txinno Bioscience Inc
Organization:
Txinno Bioscience Inc
Study Overview
Official Title:
A Multicenter Open-label Phase 1 Dose Escalation and Expansion Study of TXN10128 an Inhibitor of ENPP1 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
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 is a phase I clinical trial to primarily evaluate the safety tolerability and addtionally assess pharmacokinetics pharmacodynamics and antitumor activity of investigational product TXN10128 The target subjects will be consisted of patients with locally advanced unresectable or metastatic soild tumors
Detailed Description:
This study is a multicenter open-label phase 1 study of TXN10128 an inhibitor of ENPP1 ectonucleotide pyrophosphatasephosphodiesterase 1 Patients with locally advanced unresectable or metastatic solid tumors that have relapsed or are refractory following the last line of treatment will be enrolled
The primary objective is evaluating the safety and tolerability of TXN10128 to determine the MTD The secondary objective is characterizing the PK profile and evaluating preliminary antitumor activity of TXN10128
This study consists of the dose-escalation and dose-expansion part In dose-escalation part maximally 36 subjects can be enrolled across planned 6 dose levels Bayesian optimal interval BOIN design will be employed to find the MTD The target DLT rate for determining the MTD is 30 for this study
TXN10128 will be administered orally once daily for 21 days as a treatment cycle
The primary objective is evaluating the safety and tolerability of TXN10128 to determine the MTD The secondary objective is characterizing the PK profile and evaluating preliminary antitumor activity of TXN10128
This study consists of the dose-escalation and dose-expansion part In dose-escalation part maximally 36 subjects can be enrolled across planned 6 dose levels Bayesian optimal interval BOIN design will be employed to find the MTD The target DLT rate for determining the MTD is 30 for this study
TXN10128 will be administered orally once daily for 21 days as a treatment cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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