Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
96 participants
INTERVENTIONAL
2023-07-27
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I Study of TENPA in Advanced Solid Cancer
NCT02979392
IN10018 Combination Therapy in Previously-treated Solid Tumors
NCT05982522
TR128 in Patients With Advanced Solid Tumors
NCT05751356
A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic Nasopharyngeal Carcinoma
NCT07062484
A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors
NCT05070247
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A-1
TXN10128 Monotherapy Dose esclation part
TXN10128
TXN10128: Oral administration once daily everyday
Cohort B-1
Combination Therapy with TXN10128 and Irinotecan Dose esclation part
TXN10128
TXN10128: Oral administration once daily everyday
Irinotecan
Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle
Cohort C-1
Combination therapy with TXN10128 and Paclitaxel Dose esclation part
TXN10128
TXN10128: Oral administration once daily everyday
Paclitaxel
IV administration at 80 mg/m2 three times (Day 1, Day 8, and Day 15) at intervals of 1 week in one cycle (IV administration at 90 mg/m2 for patients with breast cancer)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TXN10128
TXN10128: Oral administration once daily everyday
Irinotecan
Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle
Paclitaxel
IV administration at 80 mg/m2 three times (Day 1, Day 8, and Day 15) at intervals of 1 week in one cycle (IV administration at 90 mg/m2 for patients with breast cancer)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Txinno Bioscience Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Min-Hee Ryu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Do-Youn Oh, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Jin Seok Ahn, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
SeHyun Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Ki-hyeong Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
Joo-Hwan Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
eoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheonju, North Chungcheong, South Korea
Seoul National Univ. Hospital
Seoul, Seoul, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
SAMSUNG Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
SeHyun Kim, MD, PhD
Role: primary
Ki-hyeong Lee, MD, PhD
Role: primary
Do-Youn Oh, M.D., Ph.D.
Role: primary
Min-Hee Ryu, M.D., Ph.D.
Role: primary
Joo-Hwan Park, MD, PhD
Role: primary
Jin Seok Ahn, MD, PhD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Homepage of Txinno Bioscience
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TXN10128-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.