A Study of TXN10128 in Subjects With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TXN10128, Irinotecan, Paclitaxel.
- Who it may be relevant to
- Registry conditions: Locally Advanced (Unresectable) or Metastatic Solid Tumors. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 as Monotherapy and Combination Therapy With Irinotecan or Paclitaxel in Locally Advanced or Metastatic Solid Tumors
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.
Detailed 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).
Interventions
- Drug TXN10128
TXN10128: Oral administration once daily everyday - Drug Irinotecan
Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle - Drug Paclitaxel
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)
Primary outcome measures
- 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]
- Adverse events (AE) [Time frame: Up to 30 days from end of treatment]
Secondary outcome measures (11)
- Cmax [Time frame: Up to 21 days from Day 1 dose]
- AUC inf [Time frame: Up to 21 days from Day 1 dose]
- AUC last [Time frame: Up to 21 days from Day 1 dose]
- Tmax [Time frame: Up to 21 days from Day 1 dose]
- T1/2 [Time frame: Up to 21 days from Day 1 dose]
- Vss [Time frame: Up to 21 days from Day 1 dose]
- Best overall response (BOR) [Time frame: Up to 30 days from end of treatment]
- Progression free survival (PFS) [Time frame: Up to 30 days from end of treatment]
- Disease control rate (DCR) [Time frame: Up to 30 days from end of treatment]
- Duration of Response (DOR) [Time frame: Up to 30 days from end of treatment]
- Overall response rate (ORR) [Time frame: Up to 30 days from end of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 6 centers
- Seoul National University Bundang Hospital — Seongnam-si
- Chungbuk National University Hospital — Cheonju
- Seoul National Univ. Hospital — Seoul
- Asan Medical Center — Seoul
- Gachon University Gil Medical Center — Incheon
- SAMSUNG Medical Center — Seoul
Identifiers
NCT: NCT05978492 · TXN10128-01