Actively Recruiting

Phase 1
Age: 19Years +
All Genders
NCT05978492

A Study of TXN10128 in Subjects With Solid Tumors

Led by Txinno Bioscience Inc. · Updated on 2025-04-24

96

Participants Needed

6

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. 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.

CONDITIONS

Official Title

A Study of TXN10128 in Subjects With Solid Tumors

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects 19 years of age or older at the time of informed consent
  • Histologically and/or cytologically confirmed progressive, locally advanced (unresectable), or metastatic solid tumors
  • Tumors relapsed or refractory after last treatment or no standard therapy exists or is appropriate
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks
Not Eligible

You will not qualify if you...

  • Presence of leptomeningeal disease
  • Experienced Grade 3 or higher immune-related adverse events with prior immunotherapy except non-clinically significant lab abnormalities
  • Prior organ transplantation
  • Known positive HIV infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

2

Chungbuk National University Hospital

Cheonju, North Chungcheong, South Korea, 28644

Actively Recruiting

3

Seoul National Univ. Hospital

Seoul, Seoul, South Korea, 03080

Actively Recruiting

4

Asan Medical Center

Seoul, Seoul, South Korea, 05505

Actively Recruiting

5

Gachon University Gil Medical Center

Incheon, South Korea, 21565

Actively Recruiting

6

SAMSUNG Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

E

Eun-Young Kwak, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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