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A Study of TXN10128 in Subjects With Solid Tumors

T

Txinno Bioscience

Status and phase

Enrolling
Phase 1

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Treatments

Drug: TXN10128
Drug: Paclitaxel
Drug: Irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT05978492
TXN10128-01

Details and patient eligibility

About

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.

Full description

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).

Enrollment

96 estimated patients

Sex

All

Ages

19 to 19 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

96 participants in 3 patient groups

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

Trial contacts and locations

6

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Central trial contact

Eun-Young Kwak, Ph.D.

Data sourced from clinicaltrials.gov

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