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A Study of TXN10128 in Subjects With Solid Tumors

NCT05978492 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-04-24

No results posted yet for this study

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.

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

  • Locally Advanced (Unresectable) or Metastatic Solid Tumors

Interventions

DRUG

TXN10128

TXN10128: Oral administration once daily everyday

DRUG

Irinotecan

Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle

DRUG

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)

Sponsors & Collaborators

  • Txinno Bioscience Inc.

    lead INDUSTRY

Principal Investigators

  • Min-Hee Ryu, M.D., Ph.D. · Asan Medical Center

  • Do-Youn Oh, M.D., Ph.D. · Seoul National University Hospital

  • Jin Seok Ahn, M.D., Ph.D. · Samsung Medical Center

  • SeHyun Kim, M.D., Ph.D. · Seoul National University Bundang Hospital

  • Ki-hyeong Lee, M.D., Ph.D. · Chungbuk National University Hospital

  • Joo-Hwan Park, M.D., Ph.D. · eoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-27
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978492 on ClinicalTrials.gov