A Study of TXN10128 in Subjects With Solid Tumors

NCT05978492 | Recruiting Phase 1

• 1 other identifier: TXN10128-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

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. 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

Keywords

ENPP1; ENPP1 inhibitor; TXN10128; TxinnoBio; Txinno Bioscience; Innate immune; STING pathway

Outcome Measures

Primary Outcomes (2)

• DLT

  A DLT is defined as any of the following AEs (graded using NCI CTCAE v5.0) whose relationship to TXN10128 cannot be ruled out.

  Day 1 up to Day 21 for Cohort A(TXN10128 mono cohort) and Day 1 up to Day 28 for Cohort B,C(TXN10128 combination with Irinotecan or paclitaxel cohort) in dose escalation period

• Adverse events (AE)

  Adverse events (AE) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0 at each dose level

  Up to 30 days from end of treatment

Secondary Outcomes (11)

• Cmax

  Up to 21 days from Day 1 dose

• AUC inf

  Up to 21 days from Day 1 dose

• AUC last

  Up to 21 days from Day 1 dose

• Tmax

  Up to 21 days from Day 1 dose

• T1/2

  Up to 21 days from Day 1 dose

Study Arms (3)

Cohort A-1

EXPERIMENTAL

TXN10128 Monotherapy Dose esclation part

Drug: TXN10128

Cohort B-1

EXPERIMENTAL

Combination Therapy with TXN10128 and Irinotecan Dose esclation part

Drug: TXN10128; Drug: Irinotecan

Cohort C-1

EXPERIMENTAL

Combination therapy with TXN10128 and Paclitaxel Dose esclation part

Drug: TXN10128; Drug: Paclitaxel

Interventions

TXN10128 DRUG

TXN10128: Oral administration once daily everyday

Cohort A-1; Cohort B-1; Cohort C-1

Irinotecan DRUG

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

Cohort B-1

Paclitaxel DRUG

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)

Cohort C-1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Txinno Bioscience Inc.: lead

Study Sites (6)

Seoul National University Bundang Hospital

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

RECRUITING

Chungbuk National University Hospital

Cheonju, North Chungcheong, 28644, South Korea

RECRUITING

Seoul National Univ. Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul, 05505, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

SAMSUNG Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Links

• Homepage of Txinno Bioscience

MeSH Terms

Interventions

Irinotecan; Paclitaxel

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Min-Hee Ryu, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Do-Youn Oh, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Jin Seok Ahn, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• SeHyun Kim, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Ki-hyeong Lee, M.D., Ph.D.

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Joo-Hwan Park, M.D., Ph.D.

  eoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun-Young Kwak, Ph.D.

CONTACT

82 31 778 8688; bella@txinno.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 7, 2023
• Study Start: July 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

KR (6)