Health TrialsbyHealthPanel

A Study of TXN10128 in Subjects With Solid Tumors

ConditionLocally Advanced (Unresectable) or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorTxinno Bioscience Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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)

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: Cohort A-1Experimental treatment 1 intervention
Group B: Cohort B-1Experimental treatment 2 interventions
Group C: Cohort C-1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Cmax

The time to reach the maximum observed concentration (time)

Time frame
Up to 21 days from Day 1 dose
2

AUC inf

The area under the concentration-time curve extrapolated to infinity (mass\*time/volume)

Time frame
Up to 21 days from Day 1 dose
3

AUC last

The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass\* time/volume)

Time frame
Up to 21 days from Day 1 dose
4

Tmax

The time to reach the maximum observed concentration (time)

Time frame
Up to 21 days from Day 1 dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Txinno Bioscience Inc.

Lead sponsor

Source ClinicalTrials.gov
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