A Study of TXN10128 in Subjects With Solid Tumors

Sponsor
Txinno Bioscience Inc.
Study ID
NCT05978492
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced (Unresectable) or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TXN10128 — DRUG
    TXN10128: Oral administration once daily everyday
  • Irinotecan — DRUG
    Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle
  • 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)

Study Details

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.

Key Dates

Start date
Jul 27, 2023
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A-1
    TXN10128 Monotherapy Dose esclation part
  • Experimental: Cohort B-1
    Combination Therapy with TXN10128 and Irinotecan Dose esclation part
  • Experimental: Cohort C-1
    Combination therapy with TXN10128 and Paclitaxel Dose esclation part

Primary Outcome Measure

DLT [ 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 ]

Central Contacts

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