Trial Title:
A Study of TXN10128 in Subjects With Solid Tumors
NCT ID:
NCT05978492
Condition:
Locally Advanced (Unresectable) or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
ENPP1
ENPP1 inhibitor
TXN10128
TxinnoBio
Txinno Bioscience
Innate immune
STING pathway
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TXN10128
Description:
Participants receive TXN10128 capsules orally once daily.
Arm group label:
Dose-escalation part
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 pyrophosphatase/phosphodiesterase 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female subjects ≥19 years of age at the time of informed consent.
- Histologically and/or cytologically confirmed any progressive, locally advanced
(unresectable), or metastatic solid tumors that have relapsed or are refractory
following the last line of treatment and for which prior standard therapy has been
ineffective, or standard therapy does not exist or is not considered appropriate.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
Exclusion Criteria:
- Has leptomeningeal disease.
- Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy
with the exception of non-clinically significant laboratory abnormalities.
- Prior organ transplantation.
- Known positive human immunodeficiency virus (HIV) infection.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheonju
Zip:
28644
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Ki-hyeong Lee, MD, PhD
Investigator:
Last name:
Ki-hyeong Lee, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
SeHyun Kim, MD, PhD
Investigator:
Last name:
SeHyun Kim, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Seoul National Univ. Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Do-Youn Oh, M.D., Ph.D.
Investigator:
Last name:
Do-Youn Oh, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min-Hee Ryu, M.D., Ph.D.
Investigator:
Last name:
Min-Hee Ryu, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
SAMSUNG Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin Seok Ahn, MD, PhD
Investigator:
Last name:
Jin Seok Ahn, MD, PhD
Email:
Principal Investigator
Start date:
July 27, 2023
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Txinno Bioscience Inc.
Agency class:
Industry
Source:
Txinno Bioscience Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978492
http://www.txinno.com
