Status:
RECRUITING
A Study of TXN10128 in Subjects With Solid Tumors
Lead Sponsor:
Txinno Bioscience Inc.
Conditions:
Locally Advanced (Unresectable) or Metastatic Solid Tumors
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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....
Detailed Description
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. The study includes dose-escala...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05978492
Start Date
July 27 2023
End Date
June 30 2026
Last Update
April 24 2025
Active Locations (6)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
2
Chungbuk National University Hospital
Cheonju, North Chungcheong, South Korea, 28644
3
Seoul National Univ. Hospital
Seoul, Seoul, South Korea, 03080
4
Asan Medical Center
Seoul, Seoul, South Korea, 05505