A Study of TXN10128 in Subjects With Solid Tumors

Phase 1RecruitingNCT05978492

Txinno Bioscience Inc.96 enrolled

Overview

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.

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-escalation and dose-expansion parts across three cohorts: TXN10128 monotherapy (Cohorts A) TXN10128 + Irinotecan (Cohorts B) and TXN10128+ Paclitaxel (Cohorts C).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Interventions

TXN10128DRUG

TXN10128: Oral administration once daily everyday

IrinotecanDRUG

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

PaclitaxelDRUG

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

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (6)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Chungbuk National University Hospital

Cheonju, North Chungcheong, South Korea

RECRUITING

Seoul National Univ. Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Up to 30 days from end of treatment