A Study of TXN10128 in Subjects With Solid Tumors

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